Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis (NCT NCT02618187)
NCT ID: NCT02618187
Last Updated: 2019-06-20
Results Overview
Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
Day 246
Results posted on
2019-06-20
Participant Flow
Participant milestones
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
15
|
17
|
|
Overall Study
Completed
|
13
|
10
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
9
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=15 Participants
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=11 Participants
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=15 Participants
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=17 Participants
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 16.12 • n=99 Participants
|
45.8 years
STANDARD_DEVIATION 15.20 • n=107 Participants
|
47.8 years
STANDARD_DEVIATION 18.59 • n=206 Participants
|
47.9 years
STANDARD_DEVIATION 11.18 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 15.00 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other - Indian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Montreal Classification
Ulcerative Proctitis
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Montreal Classification
Left-sided UC (distal UC)
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Montreal Classification
Extensive UC (pancolitis)
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Severity of UC
Mild
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Severity of UC
Moderate
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Receiving UC Treatment Prior to or On Date of First Pre-treatment Dose
No
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Receiving UC Treatment Prior to or On Date of First Pre-treatment Dose
Yes
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Time Since First UC Diagnosis
|
149.1 months
STANDARD_DEVIATION 141.34 • n=99 Participants
|
138.2 months
STANDARD_DEVIATION 85.91 • n=107 Participants
|
152.9 months
STANDARD_DEVIATION 143.77 • n=206 Participants
|
142.1 months
STANDARD_DEVIATION 105.41 • n=7 Participants
|
146.0 months
STANDARD_DEVIATION 120.12 • n=31 Participants
|
PRIMARY outcome
Timeframe: Day 246Population: Safety population
Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
Outcome measures
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=15 Participants
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=11 Participants
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=15 Participants
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=17 Participants
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Safety and Tolerability of SER-287
GI-Abnormal faeces
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Bowel movement irregularity
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability of SER-287
GI-Gastrooesophageal reflux disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
GI-Rectal discharge
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
Immune system disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
Injury, poisoning and procedural complications
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
Metabolism and nutrition disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
Nervous system disorders
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
Gastrointestinal disorders (GI) - total
|
7 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
|
Safety and Tolerability of SER-287
GI-Abdominal distension
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Abdominal pain
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Safety and Tolerability of SER-287
GI-Abdominal pain upper
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
GI-Colitis ulcerative (worsening)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Constipation
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
GI-Diarrhoea
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability of SER-287
GI-Diarrhoea haemorrhagic
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
GI-Dyspepsia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
GI-Faecal incontinence
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Flatulence
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Safety and Tolerability of SER-287
GI-Frequent bowel movements
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
GI-Mucous stools
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Nausea
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Oesophagitis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
GI-Vomiting
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
General disorders & administration site conditions
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Safety and Tolerability of SER-287
Infections and infestations
|
1 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Safety and Tolerability of SER-287
Investigations
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
Musculoskeletal and connective tissue disorders
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
Psychiatric disorders
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of SER-287
Reproductive system and breast disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of SER-287
Respiratory, thoracic and mediastinal disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety and Tolerability of SER-287
Skin and subcutaneous tissue disorders
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Sensitivity Analysis Population - 1 (all randomized subjects with an evaluable stool sample collected at baseline and one evaluable stool sample collected at Visit 12 or Early Termination (ET) visit collected within a 2 week window surrounding Visit 12)
Changes in the composition of the microbiome were characterized by whole metagenomic sequencing (WMS) of subjects' stool samples. Changes in the composition of the microbiome were measured by quantifying the number of unique types of spore-forming bacteria detected in subjects' stool samples after eight weeks of induction treatment versus baseline.
Outcome measures
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=9 Participants
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=6 Participants
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=10 Participants
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=13 Participants
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Composition of the Intestinal Microbiome
|
2.333 Richness of spore-forming species
Standard Deviation 8.588
|
0.167 Richness of spore-forming species
Standard Deviation 9.475
|
12.1 Richness of spore-forming species
Standard Deviation 9.871
|
5.615 Richness of spore-forming species
Standard Deviation 9.134
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Sensitivity Analysis Population - 1 (all randomized subjects with an evaluable stool sample collected at baseline and one evaluable stool sample collected at Visit 12 or Early Termination (ET) visit collected within a two-week window surrounding Visit 12)
The stool microbiomes of SERES-101 subjects, before and after treatment with SER-287, were characterized using whole metagenomic sequencing (WMS). SER-287 drug product was also characterized using WMS. Microbiome engraftment was assessed by the number of spore-forming species in the drug product lots that were also detected in subjects' post-treatment fecal samples but not detected at baseline.
Outcome measures
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=9 Participants
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=6 Participants
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=10 Participants
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=13 Participants
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Engraftment of SER-287 Bacteria in All Treatment Arms
|
7.222 Richness SER-287 spore-forming species
Standard Deviation 5.974
|
4.333 Richness SER-287 spore-forming species
Standard Deviation 1.862
|
16.7 Richness SER-287 spore-forming species
Standard Deviation 7.469
|
13.615 Richness SER-287 spore-forming species
Standard Deviation 6.225
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT, where the following were counted as missing: missing post-treatment endoscopy; adding UC medication for a flare during the treatment period; early termination prior to Day 48
Defined as a Total Modified Mayo Score \<= 2 and an endoscopic subscore \<= 1. The Total Modified Mayo Score is a measure of UC disease activity which ranges from 0 to 12 points and consists of four subscores (stool frequency, rectal bleeding, endoscopy, and physician global assessment), each graded from 0 to 3, with higher scores indicating more severe disease. The four components are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 12 = worst disease). The Modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
Outcome measures
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=15 Participants
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=11 Participants
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=15 Participants
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=17 Participants
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Clinical Remission
|
2 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT, where the following were counted as missing: missing post-treatment endoscopy; adding UC medication for a flare during the treatment period; early termination prior to Day 48
Defined as a decrease in endoscopic subscore \>= 1
Outcome measures
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=15 Participants
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=11 Participants
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=15 Participants
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=17 Participants
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Endoscopic Improvement
|
5 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
Adverse Events
Weekly SER-287, After Placebo Pre-Treat.
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Daily Placebo, After Placebo Pre-Treat.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Daily SER-287, After Vanco. Pre-Treat.
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Weekly SER-287, After Vanco. Pre-Treat.
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=15 participants at risk
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=11 participants at risk
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=15 participants at risk
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=17 participants at risk
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Psychiatric disorders
Worsening depression
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
6.7%
1/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/17 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
Other adverse events
| Measure |
Weekly SER-287, After Placebo Pre-Treat.
n=15 participants at risk
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat
|
Daily Placebo, After Placebo Pre-Treat.
n=11 participants at risk
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat
|
Daily SER-287, After Vanco. Pre-Treat.
n=15 participants at risk
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
Weekly SER-287, After Vanco. Pre-Treat.
n=17 participants at risk
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Number of events 4 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
9.1%
1/11 • Number of events 1 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
23.5%
4/17 • Number of events 5 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 2 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
13.3%
2/15 • Number of events 2 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/17 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 3 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
18.2%
2/11 • Number of events 3 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
11.8%
2/17 • Number of events 2 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
17.6%
3/17 • Number of events 4 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 4 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
6.7%
1/15 • Number of events 2 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
5.9%
1/17 • Number of events 1 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
13.3%
2/15 • Number of events 2 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
5.9%
1/17 • Number of events 1 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Number of events 4 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
6.7%
1/15 • Number of events 1 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
5.9%
1/17 • Number of events 2 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
0.00%
0/11 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
20.0%
3/15 • Number of events 4 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
5.9%
1/17 • Number of events 1 • Day 246
All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
|
Additional Information
Dr. Michele Trucksis, Chief Medical Officer
Seres Therapeutics
Phone: 617-945-9626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Proposed publications must be submitted to Sponsor for review at least 30 days prior to publication. Sponsor can require removal of confidential information other than study data and Site/Investigator agree to consider Sponsor's suggestions with respect to the presentation of study data. Sponsor can force publication to be deferred for a period of up to 60 days in order to file any patents.
- Publication restrictions are in place
Restriction type: OTHER