Trial Outcomes & Findings for A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome (NCT NCT03247686)
NCT ID: NCT03247686
Last Updated: 2021-04-02
Results Overview
Interferon gene expression (mean log2 fold change from baseline to Day 99). The of expression of three IFN-inducible genes (HERC5, EPSTI1, CMPK2) was measured by qPCR to assess the IFN signature status (the altered pattern of gene expression) of Sjögren's syndrome patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Day 1 and Day 99
Results posted on
2021-04-02
Participant Flow
Participants were recruited between 12 December 2016 and 01 February 2018. Participants were recruited from the Investigator's medical clinics.
Participants were randomized in a 3:1 ratio to either RSLV-132 or placebo. A total of 22 participants were randomised to RSLV-2 and 8 to placebo. Two participants randomized to RSLV-2 were withdrawn prior to the start of study treatment, one withdrew consent and one was found not to meet the eligibility criteria.
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Placebo
|
RSLV-132
Experimental drug
RSLV-132: RNase Fc fusion protein
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
20
|
|
Overall Study
COMPLETED
|
7
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo: Placebo
|
RSLV-132
Experimental drug
RSLV-132: RNase Fc fusion protein
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Placebo
Placebo: Placebo
|
RSLV-132
n=20 Participants
Experimental drug
RSLV-132: RNase Fc fusion protein
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
20 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) Total Score
|
5.1 Scores on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
5.0 Scores on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
5.1 Scores on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 99Interferon gene expression (mean log2 fold change from baseline to Day 99). The of expression of three IFN-inducible genes (HERC5, EPSTI1, CMPK2) was measured by qPCR to assess the IFN signature status (the altered pattern of gene expression) of Sjögren's syndrome patients.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo
Placebo: Placebo
|
RSLV-132 All
n=20 Participants
Experimental drug
RSLV-132: RNase Fc fusion protein
All participants receiving RSLV-132
|
RSLV-132 Responders
n=13 Participants
Experimental drug
RSLV-132: RNase Fc fusion protein
Participants receiving RSLV-132 showing a clinically meaningful improvement in two of the three patient reported outcomes
|
RSLV-132 Non-responders
n=7 Participants
Experimental drug
RSLV-132: RNase Fc fusion protein
Participants receiving RSLV-132 not showing a clinically meaningful improvement in two of the three patient reported outcomes
|
|---|---|---|---|---|
|
Blood Cell Gene Expression
Module M3.4
|
-0.0301788 log 2 fold change
Standard Error 0.1362689
|
0.08489987 log 2 fold change
Standard Error 0.08673372
|
0.1576311 log 2 fold change
Standard Error 0.1801423
|
0.0409229 log 2 fold change
Standard Error 0.08639682
|
|
Blood Cell Gene Expression
Module M1.2
|
-0.0291486 log 2 fold change
Standard Error 0.1151235
|
0.1330903 log 2 fold change
Standard Error 0.09136563
|
0.2509076 log 2 fold change
Standard Error 0.1862489
|
0.06726222 log 2 fold change
Standard Error 0.06520814
|
|
Blood Cell Gene Expression
Module M5.12
|
-0.0572555 log 2 fold change
Standard Error 0.09889587
|
0.02757946 log 2 fold change
Standard Error 0.1279434
|
0.0378753 log 2 fold change
Standard Error 0.1228119
|
0.0227104 log 2 fold change
Standard Error 0.1733785
|
SECONDARY outcome
Timeframe: Days 1, 29, 57, 85 and 99Clinical disease activity: Change from Baseline to Day 99 in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index Total Scores (imputed values with last observation carried forward). The scale ranges from 0 to 123. A higher score means more disease activity (worse outcome).
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo
Placebo: Placebo
|
RSLV-132 All
n=20 Participants
Experimental drug
RSLV-132: RNase Fc fusion protein
All participants receiving RSLV-132
|
RSLV-132 Responders
Experimental drug
RSLV-132: RNase Fc fusion protein
Participants receiving RSLV-132 showing a clinically meaningful improvement in two of the three patient reported outcomes
|
RSLV-132 Non-responders
Experimental drug
RSLV-132: RNase Fc fusion protein
Participants receiving RSLV-132 not showing a clinically meaningful improvement in two of the three patient reported outcomes
|
|---|---|---|---|---|
|
EULAR ESSDAI Total Score.
|
-2.5 Scores on a scale
Standard Deviation 4.3
|
0.0 Scores on a scale
Standard Deviation 3.8
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
RSLV-132
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo
Placebo: Placebo
|
RSLV-132
n=20 participants at risk
Experimental drug
RSLV-132: RNase Fc fusion protein
|
|---|---|---|
|
Infections and infestations
Parotitis
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo
Placebo: Placebo
|
RSLV-132
n=20 participants at risk
Experimental drug
RSLV-132: RNase Fc fusion protein
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Eye disorders
Conjunctival haemorrhage
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Eye disorders
Conjunctival hyperaemia
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Hiatus hernia
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Mouth ulceration
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
General disorders
Catheter site erythema
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
30.0%
6/20 • Number of events 7 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
15.0%
3/20 • Number of events 4 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Gastoenteritis viral
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Hordeolum
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Lower respiratory tract infection
|
37.5%
3/8 • Number of events 3 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Parotitis
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • Number of events 3 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
25.0%
5/20 • Number of events 8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 3 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Viral infection
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Infections and infestations
Viral upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
20.0%
4/20 • Number of events 6 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Injury, poisoning and procedural complications
Head injury
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.5%
1/8 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Injury, poisoning and procedural complications
Joint injury
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Injury, poisoning and procedural complications
Thermal burn
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Investigations
Weight increased
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
25.0%
5/20 • Number of events 5 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Palindromic rheumatism
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
25.0%
2/8 • Number of events 3 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
15.0%
3/20 • Number of events 4 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Nervous system disorders
Sensorimotor disorder
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Psychiatric disorders
Mood altered
|
12.5%
1/8 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
0.00%
0/20 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Psychiatric disorders
Sleep disorder
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
5.0%
1/20 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 3 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
10.0%
2/20 • Number of events 2 • 211 days
Adverse events were collected from the first dose of study treatment until the last telephone contact on Day 211
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place