Trial Outcomes & Findings for Trial of IMO-8400 in Adult Patients With Dermatomyositis (NCT NCT02612857)
NCT ID: NCT02612857
Last Updated: 2019-10-10
Results Overview
Number of participants with different types of Treatment Emergent Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
28 weeks (24 weeks treatment + 4 weeks follow up)
Results posted on
2019-10-10
Participant Flow
Participant milestones
| Measure |
Placebo
normal saline subcutaneous injections once a week for 24 weeks.
Placebo: normal saline subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 1
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1: 0.6mg/kg IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 2
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2: 1.8mg/kg IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
10
|
|
Overall Study
COMPLETED
|
8
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of IMO-8400 in Adult Patients With Dermatomyositis
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
normal saline subcutaneous injections once a week for 24 weeks.
Placebo: normal saline subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 1
n=9 Participants
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 2
n=10 Participants
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 10.55 • n=99 Participants
|
48.3 Years
STANDARD_DEVIATION 14.23 • n=107 Participants
|
54.6 Years
STANDARD_DEVIATION 14.12 • n=206 Participants
|
51.5 Years
STANDARD_DEVIATION 12.75 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 28 weeks (24 weeks treatment + 4 weeks follow up)Number of participants with different types of Treatment Emergent Adverse Events
Outcome measures
| Measure |
Placebo
n=11 Participants
normal saline subcutaneous injections once a week for 24 weeks.
Placebo: normal saline subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 1
n=9 Participants
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 2
n=10 Participants
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
|
|---|---|---|---|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Leading to Death
|
0 participants
|
0 participants
|
0 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Severity Mild
|
6 participants
|
4 participants
|
2 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Severity Moderate
|
4 participants
|
3 participants
|
6 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Severity Severe
|
1 participants
|
2 participants
|
2 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Causality Probably Related
|
3 participants
|
9 participants
|
9 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Causality Possibly Related
|
3 participants
|
0 participants
|
1 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Causality Not Related
|
5 participants
|
0 participants
|
0 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
Injection Site Reaction AE
|
2 participants
|
8 participants
|
10 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
Serious TEAE
|
0 participants
|
0 participants
|
1 participants
|
|
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
TEAE Leading to Treatment Discontinuation
|
1 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 28 weeks (24 weeks treatment + 4 weeks follow up)Population: Some patients did not complete all visits
Change from baseline in mCDASI (Cutaneous Disease and Activity Severity Index) v2-Activity score as measured at Visits 2, 6, 10, 14, 18, 22 and 26 (EOT/ Week 25). Index is Clinician administered one page instrument designed to evaluate the cutaneous manifestations of DM. CDASI yields a total score that captures overall disease state, an activity score (range:0-100) that reflects the current inflammatory state of disease and a damage score (range: 0-32). The CDASI includes separate measurements for disease activity and damage and yields a total score that captures overall disease state, an activity score that reflects the current inflammatory state of disease, and a damage score. Decreases in CDASI scores are indicative of improvement. In this study, Activity Scores were measured. The scores below are averaged.
Outcome measures
| Measure |
Placebo
n=11 Participants
normal saline subcutaneous injections once a week for 24 weeks.
Placebo: normal saline subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 1
n=9 Participants
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 2
n=10 Participants
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Baseline
|
30.1 units on a scale
Interval 29.6 to 30.56
|
31.3 units on a scale
Interval 30.72 to 31.79
|
30.7 units on a scale
Interval 30.2 to 31.22
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Visit 6
|
28.0 units on a scale
Interval 25.23 to 30.76
|
28.5 units on a scale
Interval 25.27 to 31.66
|
27.8 units on a scale
Interval 24.91 to 30.71
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Visit 10
|
27.7 units on a scale
Interval 23.66 to 31.83
|
30.4 units on a scale
Interval 25.54 to 35.26
|
25.7 units on a scale
Interval 21.4 to 30.07
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Visit 14
|
28.9 units on a scale
Interval 24.46 to 33.35
|
29.4 units on a scale
Interval 24.17 to 34.7
|
21.6 units on a scale
Interval 16.75 to 26.51
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Visit 18
|
30.5 units on a scale
Interval 25.71 to 35.22
|
26.0 units on a scale
Interval 19.98 to 32.09
|
22.4 units on a scale
Interval 17.24 to 27.63
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Visit 22
|
26.6 units on a scale
Interval 20.59 to 32.61
|
25.3 units on a scale
Interval 18.4 to 32.13
|
24.6 units on a scale
Interval 18.39 to 30.82
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Visit 26
|
26.0 units on a scale
Interval 20.97 to 31.04
|
22.1 units on a scale
Interval 16.19 to 28.01
|
23.0 units on a scale
Interval 17.38 to 28.61
|
|
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Across Visit
|
28.3 units on a scale
Interval 24.74 to 31.77
|
27.6 units on a scale
Interval 23.41 to 31.72
|
25.1 units on a scale
Interval 21.36 to 28.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
IMO-8400 Dose Group 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
IMO-8400 Dose Group 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=11 participants at risk
normal saline subcutaneous injections once a week for 24 weeks.
Placebo: normal saline subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 1
n=9 participants at risk
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 2
n=10 participants at risk
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
Other adverse events
| Measure |
Placebo
n=11 participants at risk
normal saline subcutaneous injections once a week for 24 weeks.
Placebo: normal saline subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 1
n=9 participants at risk
IMO-8400 Dose Group 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 1: IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
|
IMO-8400 Dose Group 2
n=10 participants at risk
IMO-8400 Dose Group 2 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose Group 2: IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
|
|---|---|---|---|
|
General disorders
Injection Site Erythema
|
9.1%
1/11 • 28 weeks
|
77.8%
7/9 • 28 weeks
|
100.0%
10/10 • 28 weeks
|
|
General disorders
Injection Site Pain
|
0.00%
0/11 • 28 weeks
|
66.7%
6/9 • 28 weeks
|
70.0%
7/10 • 28 weeks
|
|
General disorders
Injection Site Induration
|
0.00%
0/11 • 28 weeks
|
55.6%
5/9 • 28 weeks
|
50.0%
5/10 • 28 weeks
|
|
General disorders
Injection Site Pruritis
|
0.00%
0/11 • 28 weeks
|
33.3%
3/9 • 28 weeks
|
50.0%
5/10 • 28 weeks
|
|
General disorders
Injection Site Bruising
|
0.00%
0/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
40.0%
4/10 • 28 weeks
|
|
General disorders
Fatigue
|
0.00%
0/11 • 28 weeks
|
33.3%
3/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
General disorders
Injection Site Vesicles
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
30.0%
3/10 • 28 weeks
|
|
General disorders
Injection Site Haematoma
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Injection Site Rash
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Gastrointestinal disorders
Malaise
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
General disorders
Application Site Alopecia
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Asthenia
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
General disorders
Chest Pain
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Feeling Hot
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
General disorders
Influenza Like Illness
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Injection Site Discolouration
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Injection Site Exfoliation
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Injection Site Swelling
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
General disorders
Oedema Peripheral
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
18.2%
2/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
1/11 • 28 weeks
|
33.3%
3/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Infections and infestations
Cystitis
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Infections and infestations
Ear Infection
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Infections and infestations
Genital Herpes Simplex
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Infections and infestations
Parotitis
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Antisynthetase syndrome
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
30.0%
3/10 • 28 weeks
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Nervous system disorders
Hypersomnia
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Nervous system disorders
Neuropathy Peripheral
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Complement factor C3 decreased
|
0.00%
0/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Investigations
Anti-platelet antibody positive
|
0.00%
0/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Weight Increased
|
0.00%
0/11 • 28 weeks
|
22.2%
2/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Double stranded DNA antibody positive
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Monocyte count increased
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
18.2%
2/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
20.0%
2/10 • 28 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat Lesion
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Psychiatric disorders
Psychosomatic Disease
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Vascular disorders
Hot Flush
|
9.1%
1/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Bone Neoplasm
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/11 • 28 weeks
|
0.00%
0/9 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Eye disorders
Vision Blurred
|
0.00%
0/11 • 28 weeks
|
11.1%
1/9 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place