Trial Outcomes & Findings for Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan (NCT NCT01835470)

Last Updated: 2021-02-26

Results Overview

American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

Week 16 (Day 113)

Results posted on

2021-02-26

Participant Flow

23 participants were enrolled and 20 participants were treated. Reason for non-treatment was that 3 participants no longer met study criteria.

Participant milestones

Participant milestones
Measure	Abatacept Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Short Term Treatment Period (to Week 16) STARTED	20
Short Term Treatment Period (to Week 16) COMPLETED	20
Short Term Treatment Period (to Week 16) NOT COMPLETED	0
Long Term Treatment Period STARTED	20
Long Term Treatment Period COMPLETED	16
Long Term Treatment Period NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Abatacept Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Long Term Treatment Period Subject Request to Discontinue	1
Long Term Treatment Period Lack of Efficacy	3

Baseline Characteristics

Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.2 years STANDARD_DEVIATION 3.24 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	20 Participants n=5 Participants
Region of Enrollment Japan	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16 (Day 113)

Population: All Treated Participants: All participants who received at least one dose of study medication

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16	90.0 percentage of participants Interval 68.3 to 98.8

SECONDARY outcome

Timeframe: Week 16 (Day 113)

Population: All Treated Participants: All participants who received at least one dose of study medication

ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician's global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 ACR PED 50	75.0 percentage of participants Interval 50.9 to 91.3
Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 ACR PED 70	70.0 percentage of participants Interval 45.7 to 88.1
Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 ACR PED 90	35.0 percentage of participants Interval 15.4 to 59.2
Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16 Inactive Disease	25.0 percentage of participants Interval 8.7 to 49.1

SECONDARY outcome

Timeframe: Week 16 (Day 113)

Population: All Treated Participants: All participants who received at least one dose of study medication

Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100.

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16	43.18 percentage of improvement from baseline Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months

Population: All Treated Participants: All participants who received at least one dose of study medication

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first.

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period Death	0 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period SAEs	2 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period Drug-Related SAEs	1 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period Discontinuation Due to Drug-Related SAEs	0 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period Drug-Related AEs	5 participants
Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period Discontinuation Due to Drug-Related AEs	0 participants

SECONDARY outcome

Timeframe: 9 time points up to Week 16 (Day 113)

Population: Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).

Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period Day 57	163.13 ug/mL Geometric Coefficient of Variation 26.22
Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period Day 85	172.43 ug/mL Geometric Coefficient of Variation 23.15
Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period Day 113	167.85 ug/mL Geometric Coefficient of Variation 18.42

SECONDARY outcome

Timeframe: 9 time points up to Week 16 (Day 113)

Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period Day 113	15.56 ug/mL Geometric Coefficient of Variation 36.61
Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period Day 15	25.50 ug/mL Geometric Coefficient of Variation 27.61
Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period Day 29	38.64 ug/mL Geometric Coefficient of Variation 29.08
Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period Day 57	17.24 ug/mL Geometric Coefficient of Variation 36.63
Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period Day 85	16.79 ug/mL Geometric Coefficient of Variation 40.01

SECONDARY outcome

Timeframe: Day 1 up to Week 16 (Day 113)

Population: Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication

A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose.

Outcome measures

Outcome measures
Measure	Abatacept n=20 Participants Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Number of Participants With Positive Immunogenicity During the Short Term Period	0 participants

Adverse Events

IV ABATACEPT

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IV ABATACEPT n=20 participants at risk
Infections and infestations ENTEROCOLITIS VIRAL	5.0% 1/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations GASTROENTERITIS	5.0% 1/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations VARICELLA	5.0% 1/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations VIRAL TONSILLITIS	5.0% 1/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	5.0% 1/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Musculoskeletal and connective tissue disorders JUVENILE IDIOPATHIC ARTHRITIS	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)

Other adverse events

Other adverse events
Measure	IV ABATACEPT n=20 participants at risk
Eye disorders DRY EYE	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders ABDOMINAL PAIN	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders ABDOMINAL PAIN UPPER	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders APHTHOUS ULCER	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders CONSTIPATION	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders DIARRHOEA	25.0% 5/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders NAUSEA	20.0% 4/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders STOMATITIS	35.0% 7/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders TOOTHACHE	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Gastrointestinal disorders VOMITING	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
General disorders PYREXIA	20.0% 4/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Immune system disorders SEASONAL ALLERGY	25.0% 5/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations ANGULAR CHEILITIS	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations BRONCHITIS	25.0% 5/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations CONJUNCTIVITIS	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations ENTEROCOLITIS VIRAL	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations GASTROENTERITIS	20.0% 4/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations INFLUENZA	50.0% 10/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations NASOPHARYNGITIS	85.0% 17/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations PHARYNGITIS	60.0% 12/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations RHINITIS	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	20.0% 4/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Infections and infestations VIRAL PHARYNGITIS	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Injury, poisoning and procedural complications ARTHROPOD BITE	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Injury, poisoning and procedural complications CONTUSION	30.0% 6/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Injury, poisoning and procedural complications LIGAMENT SPRAIN	35.0% 7/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Injury, poisoning and procedural complications SKIN ABRASION	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Investigations INFLUENZA B VIRUS TEST POSITIVE	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Musculoskeletal and connective tissue disorders ARTHRALGIA	25.0% 5/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Musculoskeletal and connective tissue disorders BACK PAIN	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Musculoskeletal and connective tissue disorders MYALGIA	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Musculoskeletal and connective tissue disorders TENDONITIS	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Nervous system disorders HEADACHE	35.0% 7/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Respiratory, thoracic and mediastinal disorders COUGH	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Respiratory, thoracic and mediastinal disorders EPISTAXIS	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	30.0% 6/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders ACNE	25.0% 5/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders ALOPECIA	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders DERMATITIS	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders DRY SKIN	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders ECZEMA	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders PURPURA	10.0% 2/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)
Skin and subcutaneous tissue disorders RASH	15.0% 3/20 • During the cumulative period which is from the first dose date up to 56 days beyond the last dose of study medication in the LT period for participants entering the LT or up to 56 days beyond the last dose of study medication in the ST period for participants not entering the LT period From September 2013 to July 2018 (approximately 61 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER