Trial Outcomes & Findings for Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT02405442)
NCT ID: NCT02405442
Last Updated: 2019-04-23
Results Overview
Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Week 8
Results posted on
2019-04-23
Participant Flow
Participants were enrolled at study sites in North America, Europe, South Africa, and Asia Pacific. The first participant was screened on 30 April 2015. The last study visit occurred on 22 December 2016.
315 participants were screened.
Participant milestones
| Measure |
Andecaliximab 150 mg Every 2 Weeks
Double-Blind Phase: Participants received 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
|---|---|---|---|---|
|
Double-Blind Phase (up to Week 8)
STARTED
|
53
|
53
|
53
|
28
|
|
Double-Blind Phase (up to Week 8)
COMPLETED
|
52
|
48
|
47
|
27
|
|
Double-Blind Phase (up to Week 8)
NOT COMPLETED
|
1
|
5
|
6
|
1
|
|
Open-Label Phase (up to Week 52)
STARTED
|
52
|
48
|
47
|
26
|
|
Open-Label Phase (up to Week 52)
COMPLETED
|
4
|
3
|
2
|
2
|
|
Open-Label Phase (up to Week 52)
NOT COMPLETED
|
48
|
45
|
45
|
24
|
|
Extended Treatment Phase(up to Week 208)
STARTED
|
3
|
2
|
2
|
2
|
|
Extended Treatment Phase(up to Week 208)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Extended Treatment Phase(up to Week 208)
NOT COMPLETED
|
3
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Andecaliximab 150 mg Every 2 Weeks
Double-Blind Phase: Participants received 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
|---|---|---|---|---|
|
Double-Blind Phase (up to Week 8)
Adverse Event
|
0
|
2
|
4
|
1
|
|
Double-Blind Phase (up to Week 8)
Withdrew Consent
|
0
|
1
|
2
|
0
|
|
Double-Blind Phase (up to Week 8)
Study Disease-Related Symptoms
|
1
|
1
|
0
|
0
|
|
Double-Blind Phase (up to Week 8)
Investigator's Discretion
|
0
|
1
|
0
|
0
|
|
Open-Label Phase (up to Week 52)
Study Terminated by Sponsor
|
27
|
28
|
28
|
13
|
|
Open-Label Phase (up to Week 52)
Investigator's Discretion
|
14
|
11
|
11
|
2
|
|
Open-Label Phase (up to Week 52)
Adverse Event
|
6
|
1
|
2
|
6
|
|
Open-Label Phase (up to Week 52)
Study Disease-Related Symptoms
|
0
|
1
|
3
|
2
|
|
Open-Label Phase (up to Week 52)
Withdrew Consent
|
1
|
2
|
1
|
1
|
|
Open-Label Phase (up to Week 52)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Open-Label Phase (up to Week 52)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Extended Treatment Phase(up to Week 208)
Study Terminated by Sponsor
|
2
|
1
|
2
|
2
|
|
Extended Treatment Phase(up to Week 208)
Investigator's Discretion
|
0
|
1
|
0
|
0
|
|
Extended Treatment Phase(up to Week 208)
Study Disease-Related Symptoms
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Andecaliximab 150 mg Every 2 Weeks
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
n=28 Participants
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
39 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
42 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
38 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
39 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Full Analysis Set included all randomized participants who received at least 1 dose of study drug.
Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.
Outcome measures
| Measure |
Andecaliximab 150 mg Every 2 Weeks
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
n=28 Participants
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase
|
17.0 percentage of participants
Interval 8.1 to 29.8
|
13.2 percentage of participants
Interval 5.5 to 25.3
|
11.3 percentage of participants
Interval 4.3 to 23.0
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
PRIMARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.
Outcome measures
| Measure |
Andecaliximab 150 mg Every 2 Weeks
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
n=28 Participants
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
|
11.3 percentage of participants
Interval 4.3 to 23.0
|
13.2 percentage of participants
Interval 5.5 to 25.3
|
7.5 percentage of participants
Interval 2.1 to 18.2
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
Clinical remission was defined as Crohn's Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.
Outcome measures
| Measure |
Andecaliximab 150 mg Every 2 Weeks
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
n=28 Participants
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase
|
20.8 percentage of participants
Interval 10.8 to 34.1
|
17.0 percentage of participants
Interval 8.1 to 29.8
|
11.3 percentage of participants
Interval 4.3 to 23.0
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set were analyzed.
The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing.
Outcome measures
| Measure |
Andecaliximab 150 mg Every 2 Weeks
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 150 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Andecaliximab 300 mg Weekly
n=53 Participants
Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
Placebo
n=28 Participants
Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
|
5.7 percentage of participants
Interval 1.2 to 15.7
|
1.9 percentage of participants
Interval 0.0 to 10.1
|
1.9 percentage of participants
Interval 0.0 to 10.1
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
Adverse Events
Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Double-Blind Andecaliximab 150 mg Weekly (QW)
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Double-Blind Andecaliximab 300 mg Weekly
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Double-Blind Placebo
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W
Serious events: 9 serious events
Other events: 22 other events
Deaths: 0 deaths
Open-Label Andecaliximab QW From Andecaliximab 150 mg QW
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Open-Label Andecaliximab QW From Andecaliximab 300 mg QW
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Open-Label Andecaliximab QW From Placebo
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W)
n=53 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 1 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
|
Double-Blind Andecaliximab 150 mg Weekly (QW)
n=53 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
|
Double-Blind Andecaliximab 300 mg Weekly
n=53 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
|
Double-Blind Placebo
n=28 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
|
Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W
n=52 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Every 2 Weeks group.
|
Open-Label Andecaliximab QW From Andecaliximab 150 mg QW
n=48 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Weekly group.
|
Open-Label Andecaliximab QW From Andecaliximab 300 mg QW
n=47 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 300 mg Every 2 Weeks group.
|
Open-Label Andecaliximab QW From Placebo
n=26 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Placebo group.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
5.7%
3/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
4/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
10.4%
5/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
8.5%
4/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
11.5%
3/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
4.3%
2/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute prerenal failure
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W)
n=53 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 1 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.
|
Double-Blind Andecaliximab 150 mg Weekly (QW)
n=53 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.
|
Double-Blind Andecaliximab 300 mg Weekly
n=53 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.
|
Double-Blind Placebo
n=28 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.
|
Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W
n=52 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Every 2 Weeks group.
|
Open-Label Andecaliximab QW From Andecaliximab 150 mg QW
n=48 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Weekly group.
|
Open-Label Andecaliximab QW From Andecaliximab 300 mg QW
n=47 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 300 mg Every 2 Weeks group.
|
Open-Label Andecaliximab QW From Placebo
n=26 participants at risk
Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Placebo group.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
11.3%
6/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
13.2%
7/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.5%
4/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
13.5%
7/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
6.4%
3/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
11.5%
6/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
20.8%
10/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
8.5%
4/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
19.2%
5/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
3/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
13.2%
7/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
5.8%
3/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
8.3%
4/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
5.8%
3/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
4.3%
2/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
11.3%
6/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
9.4%
5/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
5.7%
3/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
4.3%
2/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.5%
4/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
4/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
8.5%
4/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
6.2%
3/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
5.8%
3/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
5.7%
3/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.5%
4/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
4.2%
2/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.5%
4/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.7%
2/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
1/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
9.4%
5/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.5%
4/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
9.4%
5/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
1.9%
1/53 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
3.8%
2/52 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
2.1%
1/48 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/47 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
0.00%
0/26 • Double-Blind Phase: First dose of andecaliximab to Week 8; Open-Label Phase (includes adverse events occurring in the Extended Treatment Phase): First dose of open label andecaliximab to the last dose date (maximum: 200 weeks) plus 30 days
Safety Analysis Set (Double-Blind Phase and Open-Label Phase) included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER