Trial Outcomes & Findings for Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis (NCT NCT04023396)
NCT ID: NCT04023396
Last Updated: 2025-09-03
Results Overview
Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
COMPLETED
PHASE2
217 participants
week 48
2025-09-03
Participant Flow
Participant milestones
| Measure |
ABX464 50mg
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
ABX464: ABX464
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Overall Study
STARTED
|
217
|
|
Overall Study
COMPLETED
|
164
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
ABX464 50mg
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
ABX464: ABX464
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Pregnancy
|
4
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Other reason (e.g., Ukraine Crisis)
|
10
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 13.77 • n=217 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=217 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=217 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=217 Participants
|
|
Region of Enrollment
Czechia
|
12 participants
n=217 Participants
|
|
Region of Enrollment
Ukraine
|
30 participants
n=217 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=217 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=217 Participants
|
|
Region of Enrollment
Austria
|
7 participants
n=217 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=217 Participants
|
|
Region of Enrollment
Poland
|
63 participants
n=217 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=217 Participants
|
|
Region of Enrollment
Slovakia
|
16 participants
n=217 Participants
|
|
Region of Enrollment
Slovenia
|
3 participants
n=217 Participants
|
|
Region of Enrollment
France
|
24 participants
n=217 Participants
|
|
Region of Enrollment
Serbia
|
5 participants
n=217 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=217 Participants
|
PRIMARY outcome
Timeframe: week 48Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103)
|
119 Participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Proportion of patients with clinical response at week 48 Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study
Week 48
|
177 Participants
|
|
Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study
Week 96
|
158 Participants
|
SECONDARY outcome
Timeframe: week 48 and week 96Proportion of patients with endoscopic improvement at week 48 among all patients. Proportion of patients with endoscopic improvement at week 96 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability).
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Endoscopic Improvement at Weeks 48 and 96
Week 48
|
133 Participants
|
|
Endoscopic Improvement at Weeks 48 and 96
Week 96
|
128 Participants
|
SECONDARY outcome
Timeframe: week 48 and week 96Proportion of patients with endoscopic remission at week 48 among all patients. Proportion of patients with endoscopic remission at week 96 among all patients. Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Endoscopic Remission at Weeks 48 and 96
Week 48
|
72 Participants
|
|
Endoscopic Remission at Weeks 48 and 96
Week 96
|
78 Participants
|
SECONDARY outcome
Timeframe: weeks 48 and 96Population: At Week 8 of the induction study, endoscopic improvement was achieved by 70 patients; 16 patients achieved endoscopic remission
Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Sustained Endoscopic Changes at Week 48 and Week 96
Sustained endoscopic improvement at Week 48
|
53 Participants
|
|
Sustained Endoscopic Changes at Week 48 and Week 96
Sustained endoscopic remission at Week 48
|
13 Participants
|
|
Sustained Endoscopic Changes at Week 48 and Week 96
Sustained endoscopic improvement at Week 96
|
50 Participants
|
|
Sustained Endoscopic Changes at Week 48 and Week 96
Sustained endoscopic remission at Week 96
|
11 Participants
|
SECONDARY outcome
Timeframe: From baseline to week 96Population: Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week (lower than the overall number analyzed in FAS)
Change in Modified Mayo Score (MMS) at weeks 48 and 96 and in partial Modified Mayo Score (pMMS) MMS is a composite score of UC disease activity calculated as the sum of the following 3 subscores: 1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic evaluation, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. pMMS is a composite score of UC disease activity calculed as the sum of the following 2 subscores: 1. Stool frequency, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding, scored from 0 (no blood seen) to 3 (blood alone passed). The overall pMMS ranges from 0 to 6 where higher scores represent more severe disease.
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
MMS baseline ISB
|
7.0 units on a scale
Standard Deviation 1.07
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
MMS baseline BOLS
|
4.0 units on a scale
Standard Deviation 2.02
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
MMS Week 48
|
1.8 units on a scale
Standard Deviation 1.47
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
MMS Week 96
|
1.5 units on a scale
Standard Deviation 1.48
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS baseline ISB
|
4.2 units on a scale
Standard Deviation 1.01
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS baseline BOLS
|
1.8 units on a scale
Standard Deviation 1.31
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 4
|
1.4 units on a scale
Standard Deviation 1.17
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 8
|
1.4 units on a scale
Standard Deviation 1.24
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 12
|
1.3 units on a scale
Standard Deviation 1.22
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 16
|
1.3 units on a scale
Standard Deviation 1.2
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 20
|
1.2 units on a scale
Standard Deviation 1.14
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 24
|
1.1 units on a scale
Standard Deviation 1.06
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 28
|
1.1 units on a scale
Standard Deviation 1.09
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 32
|
1.0 units on a scale
Standard Deviation 1.00
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 36
|
1.0 units on a scale
Standard Deviation 0.98
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 40
|
0.9 units on a scale
Standard Deviation 0.94
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 44
|
0.9 units on a scale
Standard Deviation 0.98
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 48
|
0.8 units on a scale
Standard Deviation 0.88
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 60
|
0.7 units on a scale
Standard Deviation 0.80
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 72
|
0.7 units on a scale
Standard Deviation 0.84
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 84
|
0.7 units on a scale
Standard Deviation 0.93
|
|
Change in Modified Mayo Score and in Partial Modified Mayo Score
pMMS Week 96
|
0.7 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: From baseline to week 96Population: Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week (lower than the overall number analyzed in FAS)
Participants recorded stool frequency using a paper subject diary on a daily basis. The stool frequency subscore ranges from 0 to 3 according to the following scale: Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Stool Frequency Subscore
Stool frequency - Baseline ISB
|
2.6 score on a scale
Standard Deviation 0.66
|
|
Stool Frequency Subscore
Stool frequency - Baseline BOLS
|
1.4 score on a scale
Standard Deviation 0.94
|
|
Stool Frequency Subscore
Stool frequency - Week 4
|
1.2 score on a scale
Standard Deviation 0.89
|
|
Stool Frequency Subscore
Stool frequency - Week 8
|
1.2 score on a scale
Standard Deviation 0.93
|
|
Stool Frequency Subscore
Stool frequency - Week 12
|
1.1 score on a scale
Standard Deviation 0.93
|
|
Stool Frequency Subscore
Stool frequency - Week 16
|
1.1 score on a scale
Standard Deviation 0.93
|
|
Stool Frequency Subscore
Stool frequency - Week 20
|
1.0 score on a scale
Standard Deviation 0.92
|
|
Stool Frequency Subscore
Stool frequency - Week 24
|
1.0 score on a scale
Standard Deviation 0.83
|
|
Stool Frequency Subscore
Stool frequency - Week 28
|
0.9 score on a scale
Standard Deviation 0.87
|
|
Stool Frequency Subscore
Stool frequency - Week 32
|
0.9 score on a scale
Standard Deviation 0.78
|
|
Stool Frequency Subscore
Stool frequency - Week 36
|
0.9 score on a scale
Standard Deviation 0.82
|
|
Stool Frequency Subscore
Stool frequency - Week 40
|
0.8 score on a scale
Standard Deviation 0.8
|
|
Stool Frequency Subscore
Stool frequency - Week 44
|
0.8 score on a scale
Standard Deviation 0.8
|
|
Stool Frequency Subscore
Stool frequency - Week 48
|
0.7 score on a scale
Standard Deviation 0.79
|
|
Stool Frequency Subscore
Stool frequency - Week 60
|
0.7 score on a scale
Standard Deviation 0.73
|
|
Stool Frequency Subscore
Stool frequency - Week 72
|
0.7 score on a scale
Standard Deviation 0.76
|
|
Stool Frequency Subscore
Stool frequency - Week 84
|
0.7 score on a scale
Standard Deviation 0.77
|
|
Stool Frequency Subscore
Stool frequency - Week 96
|
0.6 score on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: From baseline to week 96Population: Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week (lower than the overall number analyzed in FAS)
Participants recorded rectal bleeding in a paper subject diary on a daily basis. Rectal bleeding score is taken as the worst subscore of the three most recent scores within 7 days prior to the visit. The rectal bleeding subscore ranges from 0 to 3 according to the following scale: Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding.
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Rectal Bleeding Score
Rectal bleeding Score - Baseline ISB
|
1.6 score on a scale
Standard Deviation 0.72
|
|
Rectal Bleeding Score
Rectal bleeding Score - Baseline BOLS
|
0.4 score on a scale
Standard Deviation 0.66
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 4
|
0.2 score on a scale
Standard Deviation 0.49
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 8
|
0.2 score on a scale
Standard Deviation 0.56
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 12
|
0.2 score on a scale
Standard Deviation 0.50
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 16
|
0.2 score on a scale
Standard Deviation 0.51
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 20
|
0.2 score on a scale
Standard Deviation 0.49
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 24
|
0.2 score on a scale
Standard Deviation 0.46
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 28
|
0.1 score on a scale
Standard Deviation 0.42
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 32
|
0.1 score on a scale
Standard Deviation 0.39
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 36
|
0.1 score on a scale
Standard Deviation 0.38
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 40
|
0.1 score on a scale
Standard Deviation 0.37
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 44
|
0.1 score on a scale
Standard Deviation 0.37
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 48
|
0.0 score on a scale
Standard Deviation 0.23
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 60
|
0.0 score on a scale
Standard Deviation 0.24
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 72
|
0.0 score on a scale
Standard Deviation 0.24
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 84
|
0.1 score on a scale
Standard Deviation 0.36
|
|
Rectal Bleeding Score
Rectal bleeding Score - Week 96
|
0.0 score on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: baseline, week 24, week 48Population: Number of patients in the Full analysis set is 217; number analyzed in different rows correspond to number of patients analysed in the relevant week
Change to baseline in C-Reactive Protein levels
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
C-Reactive Protein
Baseline BOLS
|
6.66 mg/L
Standard Deviation 12.17
|
|
C-Reactive Protein
Week 24
|
5.07 mg/L
Standard Deviation 10.43
|
|
C-Reactive Protein
Week 48
|
5.01 mg/L
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: baseline, week 24 and week 48Population: Absolute quantification (QuantaSoft Pro) of the miR-124 copy number was performed at baseline of the induction study, at week 48 and at week 96 by using droplet digital PCR technology on 115 whole blood samples and 240 rectal biopsy samples.
Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
miRNA-124 Expression
miR-124 - Rectal - Baseline
|
0.00065 copy number/cell
Standard Deviation 0.00211
|
|
miRNA-124 Expression
miR-124 - Rectal - Week 48
|
0.00255 copy number/cell
Standard Deviation 0.00252
|
|
miRNA-124 Expression
miR-124 - Sigmoidal- Baseline
|
0.00035 copy number/cell
Standard Deviation 0.00050
|
|
miRNA-124 Expression
miR-124 - Sigmoidal- Week 48
|
0.00225 copy number/cell
Standard Deviation 0.00216
|
|
miRNA-124 Expression
miR-124 - Blood- Baseline
|
0.00000 copy number/cell
Standard Deviation 0.00000
|
|
miRNA-124 Expression
miR-124 - Blood- Week 24
|
0.00011 copy number/cell
Standard Deviation 0.00015
|
|
miRNA-124 Expression
miR-124 - Blood- Week 48
|
0.00013 copy number/cell
Standard Deviation 0.00026
|
SECONDARY outcome
Timeframe: From baseline to week 96Population: the safety analysis set (SAF) included all patients who had at least one dose of investigational product
Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity. Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days. Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.
Outcome measures
| Measure |
ABX464 50mg
n=217 Participants
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Incidence and Description of Adverse Events
AEs
|
149 Participants
|
|
Incidence and Description of Adverse Events
TEAEs
|
148 Participants
|
|
Incidence and Description of Adverse Events
Related TEAEs
|
54 Participants
|
|
Incidence and Description of Adverse Events
SAEs
|
18 Participants
|
|
Incidence and Description of Adverse Events
TESAEs
|
18 Participants
|
|
Incidence and Description of Adverse Events
TEAEs leading to discontinuation of investigational product
|
26 Participants
|
|
Incidence and Description of Adverse Events
TEAEs leading to study discontinuation
|
17 Participants
|
Adverse Events
ABX464 50mg
Serious adverse events
| Measure |
ABX464 50mg
n=217 participants at risk
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Cardiac disorders
Left ventricular dysfunction
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Cardiac disorders
Palpitations
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Proctitis
|
0.92%
2/217 • Number of events 2 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Infections and infestations
Apendicitis
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Infections and infestations
COVID-19
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Infections and infestations
COVID-19 pneunomia
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Infections and infestations
Urosepsis
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Injury, poisoning and procedural complications
Injury
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma malignant
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Nervous system disorders
Facial paresis
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Nervous system disorders
Ischemic stroke
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Nervous system disorders
Polyneuropathy
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Psychiatric disorders
Depression
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.46%
1/217 • Number of events 1 • 96 weeks
no difference
|
Other adverse events
| Measure |
ABX464 50mg
n=217 participants at risk
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
|
|---|---|
|
Infections and infestations
COVID-19
|
14.3%
31/217 • Number of events 34 • 96 weeks
no difference
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
15/217 • Number of events 23 • 96 weeks
no difference
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
6/217 • Number of events 7 • 96 weeks
no difference
|
|
Infections and infestations
Pharyngitis
|
1.8%
4/217 • Number of events 4 • 96 weeks
no difference
|
|
Infections and infestations
Sinusitis
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Investigations
Blood cholesterol increased
|
3.7%
8/217 • Number of events 10 • 96 weeks
no difference
|
|
Investigations
C-reactive protein increased
|
2.8%
6/217 • Number of events 7 • 96 weeks
no difference
|
|
Investigations
Low density lipoprotein increased
|
2.3%
5/217 • Number of events 7 • 96 weeks
no difference
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
4/217 • Number of events 6 • 96 weeks
no difference
|
|
Investigations
Neutrophil count increased
|
1.8%
4/217 • Number of events 4 • 96 weeks
no difference
|
|
Investigations
Thyroxine increased
|
1.8%
4/217 • Number of events 4 • 96 weeks
no difference
|
|
Investigations
Blood alkaline phosphatase increased
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Investigations
Lipase increased
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Investigations
Platelet count decreased
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Investigations
SARS-CoV-2 test positive
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Colitis ulcerative
|
7.8%
17/217 • Number of events 20 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
8/217 • Number of events 10 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Nausea
|
3.7%
8/217 • Number of events 8 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
7/217 • Number of events 7 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
4/217 • Number of events 5 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.3%
5/217 • Number of events 5 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Gastrointestinal disorders
Constipation
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
11/217 • Number of events 15 • 96 weeks
no difference
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
12/217 • Number of events 13 • 96 weeks
no difference
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
3/217 • Number of events 6 • 96 weeks
no difference
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
4/217 • Number of events 5 • 96 weeks
no difference
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
4/217 • Number of events 5 • 96 weeks
no difference
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Nervous system disorders
Headache
|
11.5%
25/217 • Number of events 35 • 96 weeks
no difference
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
2.3%
5/217 • Number of events 12 • 96 weeks
no difference
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.3%
5/217 • Number of events 7 • 96 weeks
no difference
|
|
Metabolism and nutrition disorders
Folate deficiency
|
2.8%
6/217 • Number of events 6 • 96 weeks
no difference
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Investigations
Fecal calprotectin increased
|
4.6%
10/217 • Number of events 11 • 96 weeks
no difference
|
|
General disorders
Fatigue
|
1.8%
4/217 • Number of events 4 • 96 weeks
no difference
|
|
General disorders
Pyrexia
|
1.8%
4/217 • Number of events 4 • 96 weeks
no difference
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
4/217 • Number of events 5 • 96 weeks
no difference
|
|
Cardiac disorders
Palpitations
|
1.4%
3/217 • Number of events 4 • 96 weeks
no difference
|
|
Infections and infestations
Ear infection
|
1.4%
3/217 • Number of events 3 • 96 weeks
no difference
|
|
Vascular disorders
Hypertension
|
3.7%
8/217 • Number of events 8 • 96 weeks
no difference
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place