Trial Outcomes & Findings for ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (NCT NCT03183128)
NCT ID: NCT03183128
Last Updated: 2023-04-27
Results Overview
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
Up to Week 8
Results posted on
2023-04-27
Participant Flow
Overall, there were 51 sites in the United States and 5 sites in Canada that enrolled participants between 2017 to 2020.
Participant milestones
| Measure |
SER-109
Randomized to SER-109 arm. Assigned to receive SER-109 oral dose of 4 capsules once daily for 3 consecutive days.
|
Placebo
Randomized to matching Placebo arm. Assigned to receive Placebo oral dose of 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
93
|
|
Overall Study
Completed 8-Week Follow-up
|
84
|
65
|
|
Overall Study
COMPLETED
|
77
|
56
|
|
Overall Study
NOT COMPLETED
|
12
|
37
|
Reasons for withdrawal
| Measure |
SER-109
Randomized to SER-109 arm. Assigned to receive SER-109 oral dose of 4 capsules once daily for 3 consecutive days.
|
Placebo
Randomized to matching Placebo arm. Assigned to receive Placebo oral dose of 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
8
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
27
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
SER-109
n=89 Participants
Randomized to SER-109 arm. Assigned to receive SER-109 oral dose of 4 capsules once daily for 3 consecutive days.
|
Placebo
n=93 Participants
Randomized to matching Placebo arm. Assigned to receive Placebo oral dose of 4 capsules once daily for 3 consecutive days.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 16.5 • n=93 Participants
|
65.5 years
STANDARD_DEVIATION 16.7 • n=4 Participants
|
65.5 years
STANDARD_DEVIATION 16.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
82 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
170 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
84 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
171 Participants
n=27 Participants
|
|
Antibiotic regimen for qualifying episode
Vancomycin
|
64 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
133 Participants
n=27 Participants
|
|
Antibiotic regimen for qualifying episode
Fidaxomicin
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Week 8Population: All participants who were randomly assigned, including those who were not exposed to any study drug, were analyzed based on the treatment to which they were randomly assigned.
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Outcome measures
| Measure |
SER-109
n=89 Participants
Randomized to SER-109 arm. Assigned to receive SER-109 oral dose of 4 capsules once daily for 3 consecutive days.
|
Placebo
n=93 Participants
Randomized to matching Placebo arm. Assigned to receive Placebo oral dose of 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Recurrence of CDI up to 8 Weeks
|
11 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Up to 4, 12 and 24 weeks after treatmentPopulation: All participants who were randomly assigned, including those who were not exposed to any study drug, were analyzed based on the treatment to which they were randomly assigned.
Recurrence of CDI up to 4, 12 and 24 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Outcome measures
| Measure |
SER-109
n=89 Participants
Randomized to SER-109 arm. Assigned to receive SER-109 oral dose of 4 capsules once daily for 3 consecutive days.
|
Placebo
n=93 Participants
Randomized to matching Placebo arm. Assigned to receive Placebo oral dose of 4 capsules once daily for 3 consecutive days.
|
|---|---|---|
|
Recurrence of CDI up to 4, 12 and 24 Weeks
CDI Recurrence-Week 4
|
10 Participants
|
31 Participants
|
|
Recurrence of CDI up to 4, 12 and 24 Weeks
CDI Recurrence-Week 12
|
16 Participants
|
43 Participants
|
|
Recurrence of CDI up to 4, 12 and 24 Weeks
CDI Recurrence-Week 24
|
19 Participants
|
44 Participants
|
Adverse Events
SER-109
Serious events: 15 serious events
Other events: 77 other events
Deaths: 3 deaths
Placebo
Serious events: 19 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SER-109
n=90 participants at risk
Received SER-109 oral dose of 4 capsules once daily for 3 consecutive days
|
Placebo
n=92 participants at risk
Received matching Placebo oral dose of 4 capsules once daily for 3 consecutive days
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
3.3%
3/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
2/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Abdominal wall abscess
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Bacteremia
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Bacterial sepsis
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Clostridioides difficile colitis
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
7.6%
7/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Cystitis
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Sepsis
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
2.2%
2/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Psychiatric disorders
Depression
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Investigations
Blood potassium decreased
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Nervous system disorders
Transient ischemic attack
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Nervous system disorders
Syncope
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Renal and urinary disorders
Hematuria
|
1.1%
1/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
0.00%
0/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Eye disorders
Sclerites
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
General disorders
Asthenia
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
General disorders
Chest pain
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
Other adverse events
| Measure |
SER-109
n=90 participants at risk
Received SER-109 oral dose of 4 capsules once daily for 3 consecutive days
|
Placebo
n=92 participants at risk
Received matching Placebo oral dose of 4 capsules once daily for 3 consecutive days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
54.4%
49/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
53.3%
49/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
51.1%
46/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
60.9%
56/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Constipation
|
31.1%
28/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
23.9%
22/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
24.4%
22/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
21.7%
20/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Flatulence
|
70.0%
63/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
76.1%
70/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Gastrointestinal disorders
Nausea
|
17.8%
16/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
32.6%
30/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
General disorders
Chills
|
23.3%
21/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
23.9%
22/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
General disorders
Fatigue
|
58.9%
53/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
63.0%
58/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
5/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
1.1%
1/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.9%
26/90 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
37.0%
34/92 • 24-week follow-up
Participants were analyzed according to the treatment they actually received. Two subjects were originally assigned to SER-109 arm, but received Placebo, while 3 subjects were originally assigned to Placebo arm, but received SER-109. All adverse events were collected from Day 1 post-dosing to Week 8. From Week 8 to the end of study (Week 24), only serious adverse events and adverse events of special interest (i.e., invasive infections) were collected.
|
Additional Information
Lisa von Moltke, MD, Chief Medical Officer
Seres Therapeutics
Phone: 617-945-9626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place