TTEDD: TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Terminated

CT.gov ID

NCT00451321

Collaborator

Juvenile Diabetes Research Foundation (Other)

Enrollment

Locations

Arm

Actual Duration (Months)

5.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: Otelixizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

Actual Study Start Date :

Jul 31, 2006

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: otelixizumab	Drug: Otelixizumab Infusion

Arm

Intervention/Treatment

Experimental: otelixizumab

Drug: Otelixizumab

Infusion

Outcome Measures

Primary Outcome Measures

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Month 24]
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Number of Participants With Cytokine Release AE [Up to Month 24]
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose.
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC) [Up to Month 48]
Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Number of Participants With Abnormal Clinical Chemistry Values of PCC [Up to Month 48]
Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Number of Participants With Abnormal Urinalysis Dipstick Results [Up to Month 48]
Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as 'positive', and abnormal urine protein values were presented as 30 and 100 mg/dL.
Mean Overall Maximum Cytokines Level [Up to Week 8]
Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)-alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample.
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load [Up to Month 18]
EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented.

Secondary Outcome Measures

Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab [At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.]
Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The 'PK summary Population' was defined as participants in the 'All Subjects' Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed.
Maximum Plasma Drug Concentration (Cmax) of Otelixizumab [At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.]
PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab [At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.]
PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count [Day 8 and 28]
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The 'Pharmacodynamic (PD) summary population' was defined as participants in the 'All Subjects' Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol.
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count [Day 8 and 28]
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Mean CD4+/CD8+ Ratio [Day 8 and 28]
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count [Day 8 and 28]
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells [At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.]
Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Saturation of CD4+ and CD8+ T Cells With Otelixizumab [At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.]
Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
CD3/TCR Complexes on CD4+ and CD8+ T Cells [At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.]
Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response [Up to Month 48]
Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days [Up to Day 8]
Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration.
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) [Baseline and up to Month 48]
Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults 12 to 45 years old who are in good general health
Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
Measurable C-peptide levels

Exclusion Criteria:

Females must not be pregnant or lactating and willing to practice contraception
No prior malignancy, other than non-melanoma skin cancer
Body Mass Index (BMI) > 32 at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35294
2	GSK Investigational Site	Walnut Creek	California	United States	94598
3	GSK Investigational Site	Aurora	Colorado	United States	80045
4	GSK Investigational Site	Washington, D.C.	District of Columbia	United States	20037
5	GSK Investigational Site	Jacksonville	Florida	United States	32207
6	GSK Investigational Site	Pinellas Park	Florida	United States	33781
7	GSK Investigational Site	Chicago	Illinois	United States	60637
8	GSK Investigational Site	Baltimore	Maryland	United States	21201
9	GSK Investigational Site	Worcester	Massachusetts	United States	1655
10	GSK Investigational Site	Kalamazoo	Michigan	United States	49048
11	GSK Investigational Site	Minneapolis	Minnesota	United States	55455
12	GSK Investigational Site	Gulfport	Mississippi	United States	39501
13	GSK Investigational Site	Omaha	Nebraska	United States	68131
14	GSK Investigational Site	Mentor	Ohio	United States	44060
15	GSK Investigational Site	Rapid City	South Dakota	United States	57701
16	GSK Investigational Site	San Antonio	Texas	United States	78229-4801
17	GSK Investigational Site	Toronto	Ontario	Canada	M4G 3E8

Sponsors and Collaborators

GlaxoSmithKline
Juvenile Diabetes Research Foundation

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Click here for more information on the TTEDD study

Publications

Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00451321

Other Study ID Numbers:

115493
TRX4005

First Posted:

Mar 23, 2007

Last Update Posted:

Nov 13, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by GlaxoSmithKline

type 1 diabetes mellitus

diabetes mellitus type 1

type 1 diabetes

diabetes mellitus

diabetes

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

Participant Flow

Recruitment Details	The study was conducted at 17 centers from United States and Canada during the period 31 July 2006 to 1 December 2011.
Pre-assignment Detail	Participants from all 7 cohorts who had received a total dose <3.0 milligrams (mg) were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Period Title: Overall Study
STARTED	8	15	18	19	7	9	6	6
COMPLETED	1	10	0	7	0	0	0	0
NOT COMPLETED	7	5	18	12	7	9	6	6

Baseline Characteristics

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg	Total
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Total of all reporting groups
Overall Participants	8	15	18	19	7	9	6	6	88
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.8 (11.36)	42.3 (13.25)	18.9 (5.17)	34.6 (9.89)	36.1 (9.70)	28.9 (10.74)	37.2 (14.37)	28.8 (6.79)	31.6 (12.49)
Sex: Female, Male (Count of Participants)
Female	6 75%	5 33.3%	5 27.8%	9 47.4%	4 57.1%	5 55.6%	3 50%	2 33.3%	39 44.3%
Male	2 25%	10 66.7%	13 72.2%	10 52.6%	3 42.9%	4 44.4%	3 50%	4 66.7%	49 55.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 5.6%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.1%
White	8 100%	15 100%	16 88.9%	19 100%	7 100%	9 100%	6 100%	6 100%	86 97.7%
More than one race	0 0%	0 0%	1 5.6%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time Frame	Up to Month 24

Outcome Measure Data

Analysis Population Description
The 'All Subjects population' was defined as all participants who received at least one dose of study medication and was used in all study population and safety analyses. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
Any AEs	8 100%	15 100%	18 100%	18 94.7%	7 100%	9 100%	6 100%	6 100%
Any SAEs	1 12.5%	2 13.3%	1 5.6%	0 0%	0 0%	1 11.1%	1 16.7%	2 33.3%

2. Primary Outcome

Title	Number of Participants With Cytokine Release AE
Description	AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose.
Time Frame	Up to Month 24

Outcome Measure Data

Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
Count of Participants [Participants]	8 100%	11 73.3%	18 100%	17 89.5%	7 100%	9 100%	6 100%	6 100%

3. Primary Outcome

Title	Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Description	Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Time Frame	Up to Month 48

Outcome Measure Data

Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
Lymphocytes, low	4 50%	12 80%	18 100%	17 89.5%	7 100%	9 100%	5 83.3%	5 83.3%
WBC, low	3 37.5%	4 26.7%	12 66.7%	5 26.3%	3 42.9%	5 55.6%	3 50%	4 66.7%
Hemoglobin, high	1 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils, low	1 12.5%	2 13.3%	11 61.1%	1 5.3%	3 42.9%	2 22.2%	3 50%	2 33.3%
Platelets, low	0 0%	2 13.3%	4 22.2%	2 10.5%	0 0%	0 0%	0 0%	0 0%
Platelets, high	0 0%	0 0%	0 0%	1 5.3%	0 0%	1 11.1%	1 16.7%	0 0%

4. Primary Outcome

Title	Number of Participants With Abnormal Clinical Chemistry Values of PCC
Description	Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Time Frame	Up to Month 48

Outcome Measure Data

Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
ALT, high	1 12.5%	1 6.7%	2 11.1%	1 5.3%	0 0%	0 0%	1 16.7%	0 0%
AST, high	1 12.5%	0 0%	1 5.6%	0 0%	0 0%	0 0%	0 0%	0 0%
Fasting glucose, high	1 12.5%	0 0%	1 5.6%	0 0%	1 14.3%	0 0%	0 0%	0 0%
Fasting glucose, low	0 0%	2 13.3%	0 0%	2 10.5%	1 14.3%	2 22.2%	1 16.7%	0 0%
Potassium, high	1 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Bicarbonate, high	0 0%	0 0%	2 11.1%	0 0%	0 0%	0 0%	0 0%	0 0%
Bicarbonate, low	0 0%	1 6.7%	1 5.6%	0 0%	1 14.3%	1 11.1%	0 0%	0 0%
Calcium, low	0 0%	1 6.7%	0 0%	0 0%	1 14.3%	0 0%	1 16.7%	1 16.7%
Magnesium, high	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline phosphatase, high	0 0%	0 0%	1 5.6%	0 0%	0 0%	0 0%	0 0%	0 0%
Total billirubin, high	0 0%	0 0%	1 5.6%	2 10.5%	0 0%	0 0%	1 16.7%	1 16.7%

5. Primary Outcome

Title	Number of Participants With Abnormal Urinalysis Dipstick Results
Description	Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as 'positive', and abnormal urine protein values were presented as 30 and 100 mg/dL.
Time Frame	Up to Month 48

Outcome Measure Data

Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
Occult blood, Day 8, 3+	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Occult blood, Month 12, 1+	0 0%	1 6.7%	0 0%	0 0%	1 14.3%	0 0%	0 0%	0 0%
Occult blood, Month 12, 2+	0 0%	0 0%	0 0%	3 15.8%	0 0%	0 0%	1 16.7%	0 0%
Occult blood, Month 12, 3+	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%
Occult blood, Month 24, 1+	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Occult blood, Month 24, 3+	0 0%	0 0%	0 0%	1 5.3%	0 0%	1 11.1%	0 0%	0 0%
Occult blood, Month 36, 2+	1 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Occult blood, Month 36, 3+	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urine glucose, Day 8, 500	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urine glucose, Month 12, 100	0 0%	0 0%	0 0%	2 10.5%	0 0%	0 0%	0 0%	0 0%
Urine glucose, Month 12, 1000	2 25%	5 33.3%	0 0%	5 26.3%	1 14.3%	2 22.2%	0 0%	2 33.3%
Urine glucose, Month 12, 250	0 0%	1 6.7%	0 0%	2 10.5%	1 14.3%	1 11.1%	1 16.7%	1 16.7%
Urine glucose, Month 12, 50	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urine glucose, Month 24, 100	0 0%	1 6.7%	0 0%	1 5.3%	1 14.3%	0 0%	0 0%	0 0%
Urine glucose, Month 24, 1000	1 12.5%	3 20%	0 0%	3 15.8%	3 42.9%	2 22.2%	3 50%	2 33.3%
Urine glucose, Month 24, 250	0 0%	3 20%	0 0%	1 5.3%	2 28.6%	1 11.1%	1 16.7%	1 16.7%
Urine glucose, Month 24, 500	0 0%	1 6.7%	0 0%	2 10.5%	0 0%	1 11.1%	0 0%	1 16.7%
Urine glucose, Month 36, 1000	0 0%	2 13.3%	0 0%	5 26.3%	0 0%	2 22.2%	1 16.7%	0 0%
Urine glucose, Month 36, 250	0 0%	2 13.3%	0 0%	2 10.5%	0 0%	1 11.1%	1 16.7%	0 0%
Urine glucose, Month 36, 500	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%
Urine glucose, Month 48, 100	0 0%	1 6.7%	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%
Urine glucose, Month 48, 1000	1 12.5%	3 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urine glucose, Month 48, 250	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urine ketones, Month 12, 1+	1 12.5%	4 26.7%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%
Urine ketones, Month 12, 2+	1 12.5%	1 6.7%	0 0%	0 0%	0 0%	1 11.1%	1 16.7%	0 0%
Urine ketones, Month 12, 3+	0 0%	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%
Urine ketones, Month 24, 1+	0 0%	0 0%	0 0%	1 5.3%	0 0%	1 11.1%	1 16.7%	1 16.7%
Urine ketones, Month 24, 2+	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%
Urine ketones, Month 24, 3+	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urine ketones, Month 36, 1+	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%
Urine ketones, Month 36, 2+	0 0%	0 0%	0 0%	1 5.3%	0 0%	0 0%	2 33.3%	0 0%
Urine ketones, Month 48, 1+	0 0%	1 6.7%	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%
Leukocyte esterase, Month 12, 1+	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%
Leukocyte esterase, Month 12, 2+	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Leukocyte esterase, Month 24, 1+	0 0%	1 6.7%	0 0%	1 5.3%	0 0%	1 11.1%	0 0%	0 0%
Leukocyte esterase, Month 24, 3+	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%
Leukocyte esterase, Month 36, 1+	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%
Nitrite, Month 12, positive	0 0%	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%
Nitrite, Month 24, positive	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Nitrite, Month 36, positive	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein urine, Month 12, 30	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%
Protein urine, Month 24, 100	0 0%	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%
Protein urine, Month 48, 30	0 0%	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Mean Overall Maximum Cytokines Level
Description	Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)-alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description
All subjects Population. Only those participants available for analysis for the particular parameter are presented. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
IFN-Gamma	55.180 (NA)	20.170 (NA)	25.878 (19.0272)	20.410 (15.6070)	40.860 (NA)	9.730 (NA)	23.210 (12.7279)	30.463 (23.4652)
IL-10	146.084 (337.2007)	44.609 (48.1712)	58.743 (59.6380)	75.879 (66.3559)	80.267 (51.6266)	82.786 (68.4322)	193.065 (225.7715)	82.547 (55.4185)
IL-6	101.161 (193.9999)	71.748 (78.0909)	75.954 (63.2599)	83.739 (65.1953)	111.567 (115.1136)	121.862 (99.0309)	358.890 (544.0678)	186.593 (200.7019)
TNF-Alpha	18.079 (10.2902)	23.071 (29.9426)	34.814 (40.1511)	27.225 (37.5837)	51.503 (36.9749)	69.678 (145.2403)	50.877 (74.6931)	44.232 (51.2616)

7. Primary Outcome

Title	Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Description	EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented.
Time Frame	Up to Month 18

Outcome Measure Data

Analysis Population Description
All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
Screening, 1-10000	2 25%	1 6.7%	0 0%	1 5.3%	0 0%	1 11.1%	0 0%	0 0%
Day 14, 1-10000	1 12.5%	4 26.7%	5 27.8%	3 15.8%	1 14.3%	2 22.2%	0 0%	2 33.3%
Day 21, 1-10000	0 0%	6 40%	4 22.2%	3 15.8%	3 42.9%	3 33.3%	1 16.7%	2 33.3%
Day 21, >10000	1 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Day 28, 1-10000	2 25%	3 20%	6 33.3%	1 5.3%	3 42.9%	0 0%	2 33.3%	2 33.3%
Week 6, 1-10000	1 12.5%	3 20%	1 5.6%	2 10.5%	0 0%	2 22.2%	0 0%	1 16.7%
Week 12, 1-10000	0 0%	0 0%	2 11.1%	0 0%	0 0%	0 0%	0 0%	0 0%
Month 6, 1-10000	0 0%	0 0%	0 0%	1 5.3%	0 0%	0 0%	0 0%	2 33.3%
Month 18, 1-10000	1 12.5%	0 0%	0 0%	2 10.5%	1 14.3%	1 11.1%	1 16.7%	0 0%
Month 12, 1-10000	1 12.5%	1 6.7%	0 0%	2 10.5%	1 14.3%	4 44.4%	0 0%	0 0%

8. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab
Description	Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The 'PK summary Population' was defined as participants in the 'All Subjects' Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed.
Time Frame	At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.

Outcome Measure Data

Analysis Population Description
PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	0	15	7	9	6	3
Day 1	0.03961 (139.9399)	0.89984 (NA)
Day 4	0.01791 (48.7376)	0.02752 (78.0203)	0.06047 (809.8761)	0.02595 (NA)	0.01701 (47.9050)	0.01370 (3.6149)
Day 7	0.01789 (66.5077)	0.08946 (161.9423)	0.15744 (1108.625)	0.02332 (27.3059)	0.19563 (665.7708)	0.20039 (80.3599)
Day 8	0.01848 (73.4326)	0.14250 (93.2214)	0.08367 (280.2741)	0.06685 (188.0044)	0.62938 (256.4433)	1.34488 (567.3411)

9. Secondary Outcome

Title	Maximum Plasma Drug Concentration (Cmax) of Otelixizumab
Description	PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Time Frame	At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.

Outcome Measure Data

Analysis Population Description
PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	0	15	7	9	6	3
Day 1	0.04399 (124.5265)	0.06370 (NA)
Day 4	0.03050 (42.9529)	0.03862 (41.1649)	0.03041 (30.4698)	0.03460 (NA)	0.03160 (39.9688)	0.02739 (3.6149)
Day 7	0.02660 (37.1463)	0.06715 (41.7413)	0.05054 (41.4392)	0.03075 (26.2309)	0.12211 (118.6807)	0.12601 (68.8972)
Day 8	0.02988 (41.3271)	0.06455 (45.7850)	0.05519 (77.5056)	0.03773 (41.5855)	0.15106 (122.2439)	0.23138 (254.9093)

10. Secondary Outcome

Title	Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
Description	PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Time Frame	At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.

Outcome Measure Data

Analysis Population Description
PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	0	15	7	9	6	3
tlast, Day 1	2.150	22.250
tlast, Day 4	2.175	2.133	2.250	2.500	2.075	2.000
tlast, Day 7	2.217	4.000	12.375	2.517	4.000	4.000
tlast, Day 8	2.075	5.033	3.250	3.500	10.000	12.000
tmax, Day 1	2.083	2.42
tmax, Day 4	2.175	2.108	2.250	2.500	2.075	2.000
tmax, Day 7	2.100	2.083	2.308	2.517	2.033	3.042
tmax, Day 8	2.075	2.167	2.000	2.000	3.500	4.000

11. Secondary Outcome

Title	Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
Description	One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The 'Pharmacodynamic (PD) summary population' was defined as participants in the 'All Subjects' Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol.
Time Frame	Day 8 and 28

Outcome Measure Data

Analysis Population Description
Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	0	18	7	9	6	4
CD19+ B Cells, Baseline	0.187 (0.1360)	0.247 (0.1029)	0.288 (0.1173)	0.393 (0.2125)	0.200 (0.0873)	0.220 (0.0922)
CD19+ B Cells, Day 8, pre-dose	0.182 (0.1697)	0.180 (0.0627)	0.146 (0.0305)	0.203 (0.1019)	0.099 (0.0468)	0.151 (0.0906)
CD19+ B Cells, Day 8, 15 minutes	0.170 (0.0446)
CD19+ B Cells, Day 8, 30 minutes	0.204 (0.1094)
CD19+ B Cells, Day 8, 2 hours	0.177 (0.1528)	0.162 (0.0570)	0.087 (0.0604)	0.099 (0.0869)
CD19+ B Cells, Day 8, 2.25 hours	0.156 (0.0602)
CD19+ B Cells, Day 8, 2.5 hours	0.161 (0.0737)
CD19+ B Cells, Day 8, 4 hours	0.186 (0.1314)	0.167 (0.0699)	0.084 (0.0523)	0.083 (0.0465)
CD19+ B Cells, Day 28	0.198 (0.1978)	0.210 (0.0634)	0.156 (0.0553)	0.279 (0.1558)	0.167 (0.0470)	0.153 (0.0783)
CD4+CD25hiFoxP3+T cells, Baseline	0.0138 (0.01010)	0.0099 (0.01142)	0.0180 (0.00865)	0.0165 (0.01262)	0.0089 (0.00948)	0.0379 (0.02839)
CD4+CD25hiFoxP3+T cells, Day 8, pre-dose	0.0062 (0.00497)	0.0039 (0.00425)	0.0056 (0.00488)	0.0105 (0.00693)	0.0028 (0.00180)	0.0237 (0.01067)
CD4+CD25hiFoxP3+T cells, Day 8, 15 minutes	0.0039 (0.00549)
CD4+CD25hiFoxP3+T cells, Day 8, 30 minutes	0.0033 (0.00283)
CD4+CD25hiFoxP3+T cells, Day 8, 2 hours	0.0035 (0.00336)	0.0015 (0.00265)	0.0013 (0.00178)	0.0055 (0.00466)
CD4+CD25hiFoxP3+T cells, Day 8, 2.25 hours	0.0034 (0.00409)
CD4+CD25hiFoxP3+T cells, Day 8, 2.5 hours	0.0027 (0.00293)
CD4+CD25hiFoxP3+T cells, Day 8, 4 hours	0.0038 (0.00380)	0.0017 (0.00285)	0.0012 (0.00125)	0.0047 (0.00379)
CD4+CD25hiFoxP3+T cells, Day 28	0.0132 (0.01176)	0.0096 (0.01231)	0.0163 (0.00740)	0.0200 (0.01421)	0.0163 (0.00635)	0.0253 (0.01205)
CD8+CD25+FoxP3+T cells, Baseline	0.0001 (0.00264)	0.0032 (0.00699)	0.0230 (0.03795)	-0.0086 (0.02386)	0.0020 (0.00153)	0.0027 (0.00825)
CD8+CD25+FoxP3+T cells, Day 8, pre-dose	0.0006 (0.00211)	0.0011 (0.00302)	0.0048 (0.01791)	0.0054 (0.00563)	0.0000 (0.00213)	-0.0006 (0.00360)
CD8+CD25+FoxP3+T cells, Day 8, 15 minutes	0.0096 (0.01322)
CD8+CD25+FoxP3+T cells, Day 8, 30 minutes	0.0138 (0.03663)
CD8+CD25+FoxP3+T cells, Day 8, 2 hours	0.0020 (0.00241)	0.0005 (0.00291)	-0.0001 (0.00187)	0.0036 (0.00420)
CD8+CD25+FoxP3+T cells, Day 8, 2.25 hours	-0.0057 (0.01376)
CD8+CD25+FoxP3+T cells, Day 8, 2.5 hours	0.0045 (0.01405)
CD8+CD25+FoxP3+T cells, Day 8, 4 hours	0.0052 (0.01082)	-0.0006 (0.00443)	0.0007 (0.00085)	0.0008 (0.00459)
CD8+CD25+FoxP3+T cells, Day 28	0.0036 (0.00443)	-0.0045 (0.01304)	0.0037 (0.01012)	0.0005 (0.01527)	0.0004 (0.00382)	0.0105 (0.01099)

12. Secondary Outcome

Title	Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
Description	One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Time Frame	Day 8 and 28

Outcome Measure Data

Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	17	18	7	9	6	4
CD4+ T cells, Baseline	0.943 (0.2982)	0.841 (0.2111)	0.959 (0.2726)	0.802 (0.1535)	0.929 (0.1879)	0.961 (0.5173)	1.007 (0.2653)
CD4+ T cells, Day 8	0.636 (0.1741)
CD4+ T cells, Day 8, pre-dose	0.463 (0.1928)	0.416 (0.1511)	0.327 (0.1175)	0.329 (0.1348)	0.188 (0.0867)	0.386 (0.1154)
CD4+ T cells, Day 8, 15 minutes	0.233 (0.1504)
CD4+ T cells, Day 8, 30 minutes	0.113 (0.0779)
CD4+ T cells, Day 8, 2 hours	0.296 (0.1341)	0.210 (0.1781)	0.108 (0.1202)	0.099 (0.0553)
CD4+ T cells, Day 8, 2.25 hours	0.218 (0.1569)
CD4+ T cells, Day 8, 2.5 hours	0.117 (0.0502)
CD4+ T cells, Day 8, 4 hours	0.397 (0.1779)	0.267 (0.1799)	0.126 (0.0962)	0.112 (0.0469)
CD4+ T cells, Day 28	0.835 (0.2971)	0.812 (0.2211)	0.978 (0.3193)	0.743 (0.1846)	0.797 (0.1824)	0.927 (0.2153)	0.689 (0.2199)
CD8+ T cells, Baseline	0.586 (0.2370)	0.442 (0.1404)	0.425 (0.1213)	0.466 (0.1720)	0.519 (0.2813)	0.437 (0.1761)	0.638 (0.1711)
CD8+ T cells, Day 8	0.324 (0.1370)
CD8+ T cells, Day 8, pre-dose	0.242 (0.1133)	0.192 (0.0873)	0.149 (0.0297)	0.161 (0.0815)	0.143 (0.1248)	0.298 (0.1108)
CD8+ T cells, Day 8, 15 minutes	0.124 (0.0577)
CD8+ T cells, Day 8, 30 minutes	0.093 (0.0558)
CD2+ T cells, Day 8, 2 hours	0.183 (0.1143)	0.134 (0.0981)	0.072 (0.0776)	0.121 (0.0731)
CD8+ T cells, Day 8, 2.25 hours	0.120 (0.0563)
CD8+ T cells, Day 8, 2.5 hours	0.076 (0.0323)
CD8+ T cells, Day 8, 4 hours	0.211 (0.1255)	0.150 (0.1013)	0.095 (0.0857)	0.138 (0.0313)
CD8+ T cells, Day 28	0.533 (0.1924)	0.460 (0.1578)	0.510 (0.2168)	0.378 (0.0906)	0.444 (0.1838)	0.779 (0.3551)	0.507 (0.1596)

13. Secondary Outcome

Title	Mean CD4+/CD8+ Ratio
Description	One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Time Frame	Day 8 and 28

Outcome Measure Data

Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	17	18	7	9	6	4
Baseline	1.95 (0.952)	2.00 (0.551)	2.35 (0.783)	1.81 (0.339)	2.14 (0.846)	2.38 (1.099)	1.64 (0.465)
Day 8	2.12 (0.531)
Day 8, pre-dose	2.15 (0.965)	2.36 (0.958)	2.15 (0.467)	2.12 (0.564)	1.80 (0.932)	1.34 (0.276)
Day 8, 15 minutes	1.72 (0.684)
Day 8, 30 minutes	1.17 (0.547)
Day 8, 2 hours	1.82 (0.740)	1.51 (0.728)	1.62 (1.163)	0.85 (0.255)
Day 8, 2.25 hours	1.72 (0.731)
Day 8, 2.5 hours	1.56 (0.441)
Day 8, 4 hours	2.11 (0.906)	1.86 (0.873)	1.72 (1.079)	0.80 (0.239)
Day 8, 10 hours	1.36 (NA)
Day 28	1.69 (0.684)	1.87 (0.339)	2.08 (0.838)	2.00 (0.357)	2.02 (0.829)	1.61 (1.263)	1.38 (0.319)

14. Secondary Outcome

Title	Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count
Description	One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Time Frame	Day 8 and 28

Outcome Measure Data

Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	0	17	0	0	0	0	0
Baseline	20.71 (25.324)
Day 8	22.08 (23.486)
Day 28	35.62 (28.538)

15. Secondary Outcome

Title	Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells
Description	Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Time Frame	At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.

Outcome Measure Data

Analysis Population Description
PD summary Population. Data was not collected for this endpoint.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	0	0	0	0	0	0	0

16. Secondary Outcome

Title	Saturation of CD4+ and CD8+ T Cells With Otelixizumab
Description	Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Time Frame	At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.

Outcome Measure Data

Analysis Population Description
PD summary Population. Data was not collected for this endpoint.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	0	0	0	0	0	0	0

17. Secondary Outcome

Title	CD3/TCR Complexes on CD4+ and CD8+ T Cells
Description	Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Time Frame	At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.

Outcome Measure Data

Analysis Population Description
PD summary Population. Data was not collected for this endpoint.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	0	0	0	0	0	0	0

18. Secondary Outcome

Title	Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response
Description	Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.
Time Frame	Up to Month 48

Outcome Measure Data

Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	0	19	7	9	6	6
Count of Participants [Participants]	0 0%	0 0%	1 5.6%	0 0%	0 0%	2 22.2%	0 0%

19. Secondary Outcome

Title	Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Description	Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration.
Time Frame	Up to Day 8

Outcome Measure Data

Analysis Population Description
All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	8	15	18	19	7	9	6	6
Day 1, Analgesics	8 100%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 1, Antihistamines	8 100%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 1, IV Saline	6 75%	13 86.7%	13 72.2%	16 84.2%	3 42.9%	3 33.3%	3 50%	5 83.3%
Day 2, Analgesics	8 100%	11 73.3%	17 94.4%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 2, Antihistamines	8 100%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 2, IV Saline	7 87.5%	13 86.7%	14 77.8%	18 94.7%	4 57.1%	2 22.2%	3 50%	5 83.3%
Day 3, Analgesics	7 87.5%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 3, Antihistamines	7 87.5%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 3, IV Saline	6 75%	13 86.7%	14 77.8%	17 89.5%	4 57.1%	3 33.3%	3 50%	5 83.3%
Day 4, Analgesics	5 62.5%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 4, Antihistamines	5 62.5%	11 73.3%	18 100%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 4, IV Saline	5 62.5%	13 86.7%	14 77.8%	17 89.5%	4 57.1%	4 44.4%	3 50%	6 100%
Day 5, Analgesics	2 25%	11 73.3%	17 94.4%	19 100%	4 57.1%	6 66.7%	3 50%	6 100%
Day 5, Antihistamines	2 25%	11 73.3%	17 94.4%	18 94.7%	4 57.1%	6 66.7%	3 50%	6 100%
Day 5, IV Saline	2 25%	13 86.7%	14 77.8%	17 89.5%	4 57.1%	5 55.6%	2 33.3%	6 100%
Day 6, Analgesics	1 12.5%	15 100%	19 105.6%	4 21.1%	6 85.7%	3 33.3%	6 100%
Day 6, Antihistamines	1 12.5%	11 73.3%	19 105.6%	4 21.1%	6 85.7%	3 33.3%	6 100%
Day 6, IV Saline	0 0%	13 86.7%	17 94.4%	4 21.1%	3 42.9%	2 22.2%	6 100%
Day 7, Analgesics	11 137.5%	19 126.7%	4 22.2%	6 31.6%	3 42.9%	6 66.7%
Day 7, Antihistamines	11 137.5%	19 126.7%	3 16.7%	6 31.6%	3 42.9%	6 66.7%
Day 7, IV Saline	14 175%	18 120%	4 22.2%	3 15.8%	3 42.9%	6 66.7%
Day 8, Analgesics	12 150%	18 120%	4 22.2%	6 31.6%	3 42.9%	5 55.6%
Day 8, Antihistamines	12 150%	19 126.7%	4 22.2%	5 26.3%	2 28.6%	5 55.6%
Day 8, IV Saline	14 175%	18 120%	4 22.2%	3 15.8%	3 42.9%	5 55.6%

20. Secondary Outcome

Title	Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Description	Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value.
Time Frame	Baseline and up to Month 48

Outcome Measure Data

Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Data for only quantifiable concentration is presented.

Arm/Group Title	Otelixizumab <3.0 mg	Otelixizumab 3.1 mg	Otelixizumab 3.1 mg (5 Days)	Otelixizumab 4.35 mg	Otelixizumab 4.35 mg (ITC-15)	Otelixizumab 4.35 mg (ITC-30)	Otelixizumab 6.85 mg	Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.	Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.	Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.	Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.	Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.	Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.	Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Measure Participants	0	14	17	18	7	9	6	4
Day 28	-0.58 (0.656)	-0.44 (0.788)	-0.41 (0.404)	-0.44 (0.416)	-0.60 (0.624)	-0.88 (0.578)	-0.53 (0.737)
Week 6	0.10 (NA)	-0.20 (NA)
Week 8	-0.69 (0.825)	-0.48 (1.187)	-0.19 (0.749)	-0.48 (0.618)	-0.64 (0.838)	-0.90 (1.277)	-0.72 (1.124)
Week 10	-0.10 (NA)
Week 12	-0.35 (0.670)	-0.15 (1.272)	0.19 (0.534)	-0.37 (0.784)	-0.64 (1.180)	-0.55 (1.063)	-0.30 (1.494)
Month 4	0.08 (0.890)	0.35 (1.575)	0.39 (0.545)	-0.18 (1.061)	0.39 (1.497)	-0.17 (1.124)	0.05 (1.196)
Month 5	0.10 (0.867)	0.76 (1.790)	0.42 (0.797)	0.13 (0.999)	0.63 (1.435)	-0.07 (0.983)	0.55 (1.338)
Month 6	-0.23 (0.819)	0.43 (1.479)	0.22 (1.274)	-0.28 (0.743)	0.61 (1.655)	-0.25 (0.985)	0.00 (1.699)
Month 9	-0.43 (0.878)	1.03 (1.589)	0.26 (1.118)	0.10 (1.307)	0.19 (1.558)	-0.64 (1.076)	-0.00 (2.304)
Month 12	-0.27 (0.800)	1.31 (1.729)	0.36 (1.330)	0.90 (1.938)	0.90 (2.045)	-0.23 (0.784)	0.35 (2.412)
Month 16	-0.36 (0.886)	0.93 (1.542)	0.45 (1.591)	0.20 (1.284)	1.33 (2.368)	0.06 (0.573)	0.00 (2.358)
Month 18	-0.24 (1.184)	0.27 (1.087)	0.58 (1.476)	0.15 (1.323)	1.06 (2.277)	-0.33 (1.253)	0.42 (2.138)
Month 24	-0.32 (1.172)	0.31 (1.059)	0.38 (1.714)	1.66 (3.730)	-0.25 (1.141)	0.20 (2.117)
Month 36	-0.21 (1.212)	0.85 (1.090)	-0.10 (NA)	2.03 (3.063)	-0.55 (1.677)
Month 48	-0.24 (0.648)	0.20 (1.254)

Adverse Events

	Otelixizumab <3.0 mg		Otelixizumab 3.1 mg		Otelixizumab 3.1 mg (5 Days)		Otelixizumab 4.35 mg		Otelixizumab 4.35 mg (ITC-15)		Otelixizumab 4.35 mg (ITC-30)		Otelixizumab 6.85 mg		Otelixizumab 8.85 mg
Time Frame	All SAEs and non-SAEs were collected up to Month 24
Adverse Event Reporting Description	SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.

Arm/Group Title	Otelixizumab <3.0 mg		Otelixizumab 3.1 mg		Otelixizumab 3.1 mg (5 Days)		Otelixizumab 4.35 mg		Otelixizumab 4.35 mg (ITC-15)		Otelixizumab 4.35 mg (ITC-30)		Otelixizumab 6.85 mg		Otelixizumab 8.85 mg
Arm/Group Description	Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.		Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.		Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.		Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.		Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.		Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.		Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.		Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Otelixizumab <3.0 mg		Otelixizumab 3.1 mg		Otelixizumab 3.1 mg (5 Days)		Otelixizumab 4.35 mg		Otelixizumab 4.35 mg (ITC-15)		Otelixizumab 4.35 mg (ITC-30)		Otelixizumab 6.85 mg		Otelixizumab 8.85 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)		2/15 (13.3%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		1/6 (16.7%)		2/6 (33.3%)
Cardiac disorders
Coronary artery stenosis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infections and infestations
Meningitis enteroviral	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Urinary tract infection	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
Limb crushing injury	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		1/6 (16.7%)
Dehydration	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Hyperglycaemia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Nervous system disorders
Speech disorder	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Other (Not Including Serious) Adverse Events
	Otelixizumab <3.0 mg		Otelixizumab 3.1 mg		Otelixizumab 3.1 mg (5 Days)		Otelixizumab 4.35 mg		Otelixizumab 4.35 mg (ITC-15)		Otelixizumab 4.35 mg (ITC-30)		Otelixizumab 6.85 mg		Otelixizumab 8.85 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/8 (100%)		15/15 (100%)		18/18 (100%)		18/19 (94.7%)		7/7 (100%)		9/9 (100%)		6/6 (100%)		6/6 (100%)
Blood and lymphatic system disorders
Anaemia	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		5/9 (55.6%)		0/6 (0%)		0/6 (0%)
Lymphadenopathy	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		1/6 (16.7%)
Leukocytosis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Leukopenia	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Lymphopenia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Platelet disorder	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Cardiac disorders
Tachycardia	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		1/7 (14.3%)		1/9 (11.1%)		0/6 (0%)		1/6 (16.7%)
Palpitations	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Atrial fibrillation	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Atrial flutter	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Ear and labyrinth disorders
Vertigo	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		2/19 (10.5%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Ear pain	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Cerumen impaction	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Ear congestion	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Hypoacusis	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Motion sickness	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Endocrine disorders
Hypothyroidism	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Eye disorders
Photophobia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Dry eye	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Eyelid pain	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Ocular hyperaemia	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Retinal detachment	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Visual impairment	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Gastrointestinal disorders
Nausea	6/8 (75%)		3/15 (20%)		11/18 (61.1%)		10/19 (52.6%)		3/7 (42.9%)		1/9 (11.1%)		5/6 (83.3%)		2/6 (33.3%)
Vomiting	4/8 (50%)		2/15 (13.3%)		7/18 (38.9%)		3/19 (15.8%)		2/7 (28.6%)		0/9 (0%)		4/6 (66.7%)		2/6 (33.3%)
Diarrhoea	1/8 (12.5%)		2/15 (13.3%)		4/18 (22.2%)		2/19 (10.5%)		1/7 (14.3%)		1/9 (11.1%)		2/6 (33.3%)		1/6 (16.7%)
Abdominal pain upper	1/8 (12.5%)		1/15 (6.7%)		4/18 (22.2%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Abdominal pain	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		1/6 (16.7%)
Constipation	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Dyspepsia	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Gastrooesophageal reflux disease	0/8 (0%)		2/15 (13.3%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Abdominal discomfort	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Abdominal distension	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Abdominal pain lower	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Abdominal tenderness	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Colitis ulcerative	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Gastritis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Toothache	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
General disorders
Chills	3/8 (37.5%)		1/15 (6.7%)		5/18 (27.8%)		6/19 (31.6%)		2/7 (28.6%)		1/9 (11.1%)		4/6 (66.7%)		2/6 (33.3%)
Pyrexia	1/8 (12.5%)		3/15 (20%)		4/18 (22.2%)		3/19 (15.8%)		2/7 (28.6%)		1/9 (11.1%)		2/6 (33.3%)		3/6 (50%)
Fatigue	1/8 (12.5%)		3/15 (20%)		3/18 (16.7%)		2/19 (10.5%)		0/7 (0%)		2/9 (22.2%)		1/6 (16.7%)		0/6 (0%)
Chest pain	0/8 (0%)		1/15 (6.7%)		2/18 (11.1%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Oedema peripheral	1/8 (12.5%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Asthenia	1/8 (12.5%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infusion site phlebitis	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Infusion site erythema	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infusion site extravasation	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Temperature intolerance	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Catheter site haemorrhage	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Catheter site rash	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Influenza like illness	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Infusion site haematoma	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infusion site haemorrhage	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infusion site induration	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infusion site scab	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Injection site haematoma	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Injection site rash	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Pitting oedema	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Sensation of foreign body	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Immune system disorders
Hypersensitivity	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		1/19 (5.3%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Seasonal allergy	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		1/19 (5.3%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Infections and infestations
Nasopharyngitis	1/8 (12.5%)		3/15 (20%)		5/18 (27.8%)		7/19 (36.8%)		5/7 (71.4%)		2/9 (22.2%)		3/6 (50%)		0/6 (0%)
Upper respiratory tract infection	3/8 (37.5%)		3/15 (20%)		2/18 (11.1%)		5/19 (26.3%)		0/7 (0%)		2/9 (22.2%)		1/6 (16.7%)		1/6 (16.7%)
Sinusitis	1/8 (12.5%)		3/15 (20%)		2/18 (11.1%)		3/19 (15.8%)		1/7 (14.3%)		0/9 (0%)		2/6 (33.3%)		1/6 (16.7%)
Influenza	1/8 (12.5%)		1/15 (6.7%)		2/18 (11.1%)		1/19 (5.3%)		0/7 (0%)		2/9 (22.2%)		0/6 (0%)		1/6 (16.7%)
Urinary tract infection	1/8 (12.5%)		2/15 (13.3%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		2/9 (22.2%)		0/6 (0%)		1/6 (16.7%)
Gastroenteritis	1/8 (12.5%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		2/6 (33.3%)		0/6 (0%)
Gastroenteritis viral	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Pharyngitis	0/8 (0%)		0/15 (0%)		0/18 (0%)		3/19 (15.8%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Bronchitis	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		1/6 (16.7%)
Cellulitis	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Skin infection	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Ear infection	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Herpes simplex	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		2/6 (33.3%)		0/6 (0%)
Localised infection	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Oral herpes	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Pharyngitis streptococcal	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Tooth abscess	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Viral infection	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Bacterial infection	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Ear infection bacterial	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Eye infection	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Fungal infection	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Furuncle	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Gastroenteritis norovirus	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Infusion site cellulitis	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Lice infestation	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Lobar pneumonia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Paronychia	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Staphylococcal infection	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Tooth infection	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Viral skin infection	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Viral upper respiratory tract infection	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Injury, poisoning and procedural complications
Joint sprain	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		2/6 (33.3%)		0/6 (0%)
Procedural pain	0/8 (0%)		2/15 (13.3%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Skin laceration	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Arthropod bite	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Arthropod sting	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Chemical eye injury	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Contusion	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Excoriation	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Facial bones fracture	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Limb injury	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Meniscus lesion	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Neck injury	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Postoperative wound complication	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Radius fracture	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Tooth fracture	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Investigations
Blood iron decreased	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Epstein-Barr virus test positive	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Fibrin D dimer increased	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Glycosylated haemoglobin increased	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hormone level abnormal	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	6/8 (75%)		9/15 (60%)		9/18 (50%)		14/19 (73.7%)		4/7 (57.1%)		4/9 (44.4%)		2/6 (33.3%)		2/6 (33.3%)
Hyperglycaemia	1/8 (12.5%)		1/15 (6.7%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Dehydration	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Vitamin D deficiency	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Diabetic ketoacidosis	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Hypercholesterolaemia	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Hyperkalaemia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hypervolaemia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hypokalaemia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hyponatraemia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hypovolaemia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Weight fluctuation	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	2/8 (25%)		4/15 (26.7%)		6/18 (33.3%)		3/19 (15.8%)		0/7 (0%)		3/9 (33.3%)		3/6 (50%)		1/6 (16.7%)
Arthralgia	1/8 (12.5%)		2/15 (13.3%)		4/18 (22.2%)		3/19 (15.8%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		3/6 (50%)
Back pain	1/8 (12.5%)		1/15 (6.7%)		2/18 (11.1%)		3/19 (15.8%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		1/6 (16.7%)
Pain in extremity	1/8 (12.5%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Muscle spasms	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Muscular weakness	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Musculoskeletal pain	1/8 (12.5%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Tendonitis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Arthritis	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Arthropathy	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Fibromyalgia	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Flank pain	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Groin pain	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Intervertebral disc protrusion	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Joint range of motion decreased	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Limb discomfort	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Musculoskeletal discomfort	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Musculoskeletal stiffness	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Myositis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Neck pain	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Pain in jaw	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Psoriatic arthropathy	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rotator cuff syndrome	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Melanocytic naevus	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Benign neoplasm	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Fibrous histiocytoma	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Haemangioma	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Lipoma	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Skin papilloma	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Thyroid neoplasm	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Nervous system disorders
Headache	8/8 (100%)		12/15 (80%)		18/18 (100%)		18/19 (94.7%)		7/7 (100%)		9/9 (100%)		6/6 (100%)		6/6 (100%)
Dizziness	1/8 (12.5%)		1/15 (6.7%)		3/18 (16.7%)		5/19 (26.3%)		0/7 (0%)		1/9 (11.1%)		1/6 (16.7%)		1/6 (16.7%)
Paraesthesia	0/8 (0%)		0/15 (0%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		3/6 (50%)		0/6 (0%)
Sinus headache	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		1/9 (11.1%)		1/6 (16.7%)		0/6 (0%)
Lethargy	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		2/6 (33.3%)		0/6 (0%)
Dizziness postural	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Hypoaesthesia	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Migraine	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Neuralgia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Neuropathy peripheral	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Carpal tunnel syndrome	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Dysgeusia	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Nerve compression	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Neurological symptom	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Presyncope	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Sciatica	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Syncope vasovagal	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Psychiatric disorders
Insomnia	1/8 (12.5%)		2/15 (13.3%)		1/18 (5.6%)		4/19 (21.1%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		1/6 (16.7%)
Anxiety	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		1/6 (16.7%)
Depression	1/8 (12.5%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Alcoholism	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Disorientation	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Nervousness	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Renal and urinary disorders
Acute prerenal failure	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Dysuria	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Pollakiuria	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Reproductive system and breast disorders
Balanitis	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Breast calcifications	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Dysmenorrhoea	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Gynaecomastia	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Menorrhagia	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Ovarian cyst ruptured	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Rash maculo-papular	1/8 (12.5%)		0/15 (0%)		2/18 (11.1%)		0/19 (0%)		1/7 (14.3%)		1/9 (11.1%)		1/6 (16.7%)		2/6 (33.3%)
Oropharyngeal pain	1/8 (12.5%)		3/15 (20%)		1/18 (5.6%)		3/19 (15.8%)		1/7 (14.3%)		3/9 (33.3%)		3/6 (50%)		0/6 (0%)
Cough	0/8 (0%)		2/15 (13.3%)		2/18 (11.1%)		2/19 (10.5%)		2/7 (28.6%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Nasal congestion	1/8 (12.5%)		0/15 (0%)		3/18 (16.7%)		3/19 (15.8%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Sinus congestion	0/8 (0%)		1/15 (6.7%)		2/18 (11.1%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Wheezing	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Dyspnoea	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		1/6 (16.7%)
Epistaxis	0/8 (0%)		0/15 (0%)		2/18 (11.1%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Pharyngeal erythema	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Respiratory tract congestion	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		1/9 (11.1%)		1/6 (16.7%)		0/6 (0%)
Chronic obstructive pulmonary disease	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Dyspnoea exertional	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Pharyngeal lesion	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rhinitis allergic	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rhinorrhoea	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rhonchi	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Sneezing	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Upper respiratory tract congestion	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hypotension	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		2/19 (10.5%)		1/7 (14.3%)		1/9 (11.1%)		1/6 (16.7%)		2/6 (33.3%)
Skin and subcutaneous tissue disorders
Rash macular	0/8 (0%)		0/15 (0%)		2/18 (11.1%)		1/19 (5.3%)		2/7 (28.6%)		0/9 (0%)		2/6 (33.3%)		1/6 (16.7%)
Rash	1/8 (12.5%)		1/15 (6.7%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		1/9 (11.1%)		1/6 (16.7%)		0/6 (0%)
Rash papular	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		1/9 (11.1%)		0/6 (0%)		0/6 (0%)
Pruritus	0/8 (0%)		2/15 (13.3%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rash erythematous	1/8 (12.5%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rash pruritic	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Dermatitis contact	0/8 (0%)		1/15 (6.7%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Dry skin	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Erythema	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hyperhidrosis	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Skin lesion	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Alopecia	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Circumoral oedema	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Dermal cyst	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Dermographism	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Eczema	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Keratosis pilaris	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Lipohypertrophy	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Palmar erythema	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Periorbital oedema	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Photosensitivity reaction	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Psoriasis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Rash generalised	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Skin exfoliation	0/8 (0%)		0/15 (0%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Skin hypopigmentation	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Skin striae	0/8 (0%)		0/15 (0%)		1/18 (5.6%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Swelling face	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		1/6 (16.7%)		0/6 (0%)
Urticaria	1/8 (12.5%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Vitiligo	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Vascular disorders
Orthostatic hypotension	0/8 (0%)		2/15 (13.3%)		1/18 (5.6%)		3/19 (15.8%)		2/7 (28.6%)		0/9 (0%)		3/6 (50%)		1/6 (16.7%)
Hypertension	0/8 (0%)		2/15 (13.3%)		0/18 (0%)		1/19 (5.3%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Pallor	0/8 (0%)		2/15 (13.3%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Phlebitis	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		2/19 (10.5%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Flushing	0/8 (0%)		1/15 (6.7%)		0/18 (0%)		0/19 (0%)		0/7 (0%)		0/9 (0%)		0/6 (0%)		0/6 (0%)
Hot flush	0/8 (0%)		0/15 (0%)		0/18 (0%)		0/19 (0%)		1/7 (14.3%)		0/9 (0%)		0/6 (0%)		0/6 (0%)

Limitations/Caveats

This study was terminated on 15 December 2011

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	GSK Response Center
Organization	GlaxoSmithKline
Phone	866-435-7343
Email

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00451321

Other Study ID Numbers:

115493
TRX4005

First Posted:

Mar 23, 2007

Last Update Posted:

Nov 13, 2017

Last Verified:

Oct 1, 2017

TTEDD: TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

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