Trial Outcomes & Findings for Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis (NCT NCT02039687)
NCT ID: NCT02039687
Last Updated: 2017-04-18
Results Overview
Measurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Baseline and 28 days
Results posted on
2017-04-18
Participant Flow
Participant milestones
| Measure |
1 mg Per Day ARA 290
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
1 mg Per Day ARA 290
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
treatment assignment could not be confir
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
Baseline characteristics by cohort
| Measure |
1 mg Per Day ARA 290
n=16 Participants
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 Participants
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 Participants
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 Participants
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 7.47 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
52.2 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 10.66 • n=4 Participants
|
50.8 years
STANDARD_DEVIATION 9.55 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 28 daysMeasurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.
Outcome measures
| Measure |
1 mg Per Day ARA 290
n=16 Participants
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 Participants
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 Participants
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 Participants
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Change in Corneal Nerve Fiber Area
|
-64.3 µm^2
Standard Deviation 759.9
|
533.8 µm^2
Standard Deviation 1110.02
|
203.8 µm^2
Standard Deviation 641.2
|
-170.0 µm^2
Standard Deviation 633.0
|
SECONDARY outcome
Timeframe: Baseline and 28 daysMeasurement of the distance a patient can walk in 6 minutes
Outcome measures
| Measure |
1 mg Per Day ARA 290
n=16 Participants
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 Participants
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 Participants
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 Participants
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Change in the 6 Minute Walk Test
|
19.3 meters
Standard Deviation 79.27
|
17.7 meters
Standard Deviation 40.29
|
18.2 meters
Standard Deviation 47.9
|
1.2 meters
Standard Deviation 38.56
|
SECONDARY outcome
Timeframe: Baseline and 28 daysMeasurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy.
Outcome measures
| Measure |
1 mg Per Day ARA 290
n=16 Participants
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 Participants
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 Participants
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 Participants
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Change in Intra-epidermal Nerve Fiber Density (IENFD)
|
0.5 fibers/mm
Standard Deviation 1.58
|
0.4 fibers/mm
Standard Deviation 2.28
|
-0.3 fibers/mm
Standard Deviation 1.81
|
0.8 fibers/mm
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Questionnaires incomplete for some subjects
Change in mean score from baseline to Day 28 is recorded for each outcome. Brief Pain Inventory (BPI), Pain Severity - scale of 0 (no pain) to 10 (worst pain imaginable) in 4 time frames, averaged. BPI, Pain Interference - scale of 0 (does not interfere) to 10 (completely interferes) how pain interferes with 7 lifestyle parameters, averaged. Small Fiber Neuropathy Screening List (SFNSL) - scale of 0 to 84 (higher score indicates greater neuropathy), sum of 21 questions. Neuropathic Pain Symptom Inventory (NPSI) - scale of 0 (least pain) to 10 (most pain) in 10 questions, summed. Total score range from 0 to 100. Fatigue Assessment Scale (FAS) - scale of 1 (never) to 5 (always) in 10 questions related to fatigue, summed. Total score range from 0 to 50, with 0 being the best possible score and 50 the worst..
Outcome measures
| Measure |
1 mg Per Day ARA 290
n=16 Participants
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 Participants
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 Participants
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 Participants
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires
BPI - Pain Interference
|
-1.187 units on a scale
Standard Deviation 1.9453
|
-1.657 units on a scale
Standard Deviation 1.6482
|
-1.308 units on a scale
Standard Deviation 2.4403
|
-1.732 units on a scale
Standard Deviation 2.2174
|
|
Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires
NPSI
|
-12.31 units on a scale
Standard Deviation 16.074
|
-14.50 units on a scale
Standard Deviation 17.887
|
-8.38 units on a scale
Standard Deviation 12.699
|
-12.88 units on a scale
Standard Deviation 13.803
|
|
Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires
BPI - Pain Severity
|
-0.594 units on a scale
Standard Deviation 1.6680
|
-1.167 units on a scale
Standard Deviation 1.6894
|
-1.115 units on a scale
Standard Deviation 1.7067
|
-0.922 units on a scale
Standard Deviation 1.4429
|
|
Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires
SFNSL
|
-4.9 units on a scale
Standard Deviation 8.87
|
-8.7 units on a scale
Standard Deviation 14.17
|
-5.5 units on a scale
Standard Deviation 7.09
|
-7.3 units on a scale
Standard Deviation 9.50
|
|
Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires
FAS
|
-2.6 units on a scale
Standard Deviation 5.52
|
-2.1 units on a scale
Standard Deviation 5.38
|
-3.1 units on a scale
Standard Deviation 5.27
|
-2.2 units on a scale
Standard Deviation 6.00
|
SECONDARY outcome
Timeframe: Continuous reporting from baseline through 16 weeksPatients reporting at least one treatment emergent adverse event (TEAE) or serious TEAE
Outcome measures
| Measure |
1 mg Per Day ARA 290
n=16 Participants
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 Participants
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 Participants
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 Participants
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters
Patients reporting at least one TEAE
|
14 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
|
Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters
Patients reporting at least one serious TEAE
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
1 mg Per Day ARA 290
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
4 mg Per Day ARA 290
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
8 mg Per Day ARA 290
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg Per Day ARA 290
n=16 participants at risk
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 participants at risk
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 participants at risk
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 participants at risk
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
General disorders
Chest Tightness
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Small Bowel Enteritis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
Other adverse events
| Measure |
1 mg Per Day ARA 290
n=16 participants at risk
1 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
4 mg Per Day ARA 290
n=16 participants at risk
4 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
8 mg Per Day ARA 290
n=14 participants at risk
8 mg ARA 290 administered subcutaneously for 28 consecutive days
ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
|
Placebo
n=16 participants at risk
1 mL placebo administered subcutaneously for 28 consecutive days
Placebo: Formulation buffer
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
14.3%
2/14 • Number of events 2 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
18.8%
3/16 • Number of events 3 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Bacterial vaginosis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Mastoiditis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Oral herpes
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Orchitis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Streptococcal infection
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Infections and infestations
Viral infection
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • 28 day treatment with 84 day follow up
|
18.8%
3/16 • Number of events 3 • 28 day treatment with 84 day follow up
|
14.3%
2/14 • Number of events 2 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Tremor
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Dizziness exertional
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Retrograde Amnesia
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Nervous system disorders
Tension headache
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
General disorders
Fatigue
|
18.8%
3/16 • Number of events 4 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
|
General disorders
Injection site pain
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
25.0%
4/16 • Number of events 4 • 28 day treatment with 84 day follow up
|
|
General disorders
Feeling abnormal
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
General disorders
Asthenia
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
General disorders
Disease progression
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
General disorders
Impaired healing
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
General disorders
Injection site discomfort
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
General disorders
Injection site irritation
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
General disorders
Temperature intolerance
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
12.5%
2/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.2%
1/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Wound
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 3 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Eye disorders
Accommodation disorder
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Eye disorders
Blepharitis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Eye disorders
Conjunctival haemorrhage
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Eye disorders
Eye irritation
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Skin and subcutaneous tissue disorders
Sticky skin
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Immune system disorders
Allergy to arthropod sting
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 2 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
7.1%
1/14 • Number of events 1 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 2 • 28 day treatment with 84 day follow up
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/16 • 28 day treatment with 84 day follow up
|
0.00%
0/14 • 28 day treatment with 84 day follow up
|
6.2%
1/16 • Number of events 1 • 28 day treatment with 84 day follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60