Trial Outcomes & Findings for A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer (NCT NCT05983367)
NCT ID: NCT05983367
Last Updated: 2026-02-20
Results Overview
ORR is defined as the proportion of patients achieving a best overall response (BOR) of complete response (CR) or partial response (PR) per the investigators using RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
From randomization until development of radiographic disease progression (up to approximately 12 months).
Results posted on
2026-02-20
Participant Flow
Participants were enrolled at oncology clinical study sites.
After signing of informed consents, participants were screened to ensure they met all study eligibility criteria before they were randomized and treated with study medications. One participant in the ompenaclid group was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria.
Participant milestones
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Received curative surgery during the study treatment
|
0
|
1
|
|
Overall Study
Switched to marketed drug
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=38 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 11.48 • n=38 Participants
|
62.6 Years
STANDARD_DEVIATION 11.42 • n=38 Participants
|
62.4 Years
STANDARD_DEVIATION 11.38 • n=76 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=38 Participants
|
19 Participants
n=38 Participants
|
32 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=38 Participants
|
19 Participants
n=38 Participants
|
44 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG performance status at baseline
0
|
23 Participants
n=38 Participants
|
28 Participants
n=38 Participants
|
51 Participants
n=76 Participants
|
|
ECOG performance status at baseline
1
|
14 Participants
n=38 Participants
|
10 Participants
n=38 Participants
|
24 Participants
n=76 Participants
|
|
ECOG performance status at baseline
Missing
|
1 Participants
n=38 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
|
Primary tumor site
Ascending
|
9 Participants
n=38 Participants
|
7 Participants
n=38 Participants
|
16 Participants
n=76 Participants
|
|
Primary tumor site
Sigmoid
|
6 Participants
n=38 Participants
|
6 Participants
n=38 Participants
|
12 Participants
n=76 Participants
|
|
Primary tumor site
Cecum
|
4 Participants
n=38 Participants
|
5 Participants
n=38 Participants
|
9 Participants
n=76 Participants
|
|
Primary tumor site
Rectosigmoid
|
5 Participants
n=38 Participants
|
4 Participants
n=38 Participants
|
9 Participants
n=76 Participants
|
|
Primary tumor site
Descending
|
3 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
4 Participants
n=76 Participants
|
|
Primary tumor site
Transverse
|
1 Participants
n=38 Participants
|
3 Participants
n=38 Participants
|
4 Participants
n=76 Participants
|
|
Primary tumor site
Appendix
|
0 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
|
Primary tumor site
Double-primary with Cecum and Sigmoid
|
0 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
|
Primary tumor site
Splenic angle
|
1 Participants
n=38 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
|
Primary tumor site
Rectum
|
9 Participants
n=38 Participants
|
10 Participants
n=38 Participants
|
19 Participants
n=76 Participants
|
|
Prior bevacizumab treatment status
Prior bevacizumab treated
|
27 Participants
n=38 Participants
|
27 Participants
n=38 Participants
|
54 Participants
n=76 Participants
|
|
Prior bevacizumab treatment status
Prior bevacizumab untreated
|
11 Participants
n=38 Participants
|
11 Participants
n=38 Participants
|
22 Participants
n=76 Participants
|
|
RAS mutation status
KRAS G12D
|
9 Participants
n=38 Participants
|
9 Participants
n=38 Participants
|
18 Participants
n=76 Participants
|
|
RAS mutation status
KRAS G12V
|
6 Participants
n=38 Participants
|
7 Participants
n=38 Participants
|
13 Participants
n=76 Participants
|
|
RAS mutation status
KRAS G13D
|
5 Participants
n=38 Participants
|
8 Participants
n=38 Participants
|
13 Participants
n=76 Participants
|
|
RAS mutation status
KRAS G12A
|
3 Participants
n=38 Participants
|
3 Participants
n=38 Participants
|
6 Participants
n=76 Participants
|
|
RAS mutation status
KRAS G12C
|
4 Participants
n=38 Participants
|
2 Participants
n=38 Participants
|
6 Participants
n=76 Participants
|
|
RAS mutation status
KRAS G12S
|
3 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
4 Participants
n=76 Participants
|
|
RAS mutation status
KRAS Q61R
|
0 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
|
RAS mutation status
Other KRAS mutations
|
7 Participants
n=38 Participants
|
4 Participants
n=38 Participants
|
11 Participants
n=76 Participants
|
|
RAS mutation status
NRAS Q61K
|
1 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
2 Participants
n=76 Participants
|
|
RAS mutation status
NRAS G12D
|
0 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
|
RAS mutation status
NRAS Q61R
|
0 Participants
n=38 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: From randomization until development of radiographic disease progression (up to approximately 12 months).Population: All randomized participants (ITT: N=38 in each group), prior bevacizumab treated (N=27 in each group), prior bevacizumab untreated (N=11 in each group)
ORR is defined as the proportion of patients achieving a best overall response (BOR) of complete response (CR) or partial response (PR) per the investigators using RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=38 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Objective Response Rate
All randomized participants
|
8 Participants
|
8 Participants
|
|
Objective Response Rate
Participants treated with prior bevacizumab
|
2 Participants
|
4 Participants
|
|
Objective Response Rate
Participants untreated with prior bevacizumab
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.Population: All randomized participants (ITT: N=38 in each group)
PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease (PD) per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first (up to approximately 12 months).
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=38 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
8.8 Months
Interval 5.72 to 11.1
|
8.1 Months
Interval 5.55 to 10.94
|
SECONDARY outcome
Timeframe: From randomization until death due to any cause.Population: All randomized participants (ITT: N=38 in each group)
OS is defined as the time from the date of randomization to the date of death from any cause. The proportions of participants who have not experienced OS events (death) at 9 months and 12 months are presented.
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=38 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Overall Survival (OS)
OS rate at 9 months
|
88.5 Percentage of participants
Interval 79.5052 to 97.4717
|
69.0 Percentage of participants
Interval 55.345 to 82.6884
|
|
Overall Survival (OS)
OS rate at 12 months
|
88.5 Percentage of participants
Interval 79.5052 to 97.4717
|
61.3 Percentage of participants
Interval 44.3449 to 78.3514
|
SECONDARY outcome
Timeframe: From randomization until development of radiographic disease progression or death due to any cause, whichever comes first (up to approximately 12 months).DoR is defined as the time from the date of objectively determined PR or CR (whichever status is recorded first) to the date of PD per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first. The median DoR was not reached in both groups.
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=8 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=8 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Duration of Response (DoR)
|
NA Months
Interval 2.04 to
Too few participants experienced either disease progression or death.
|
NA Months
Too few participants experienced either disease progression or death.
|
SECONDARY outcome
Timeframe: From randomization until development of radiographic disease progression (up to approximately 12 months).Population: All randomized participants (ITT: N=38 in each group)
DCR is defined as the proportion of patients achieving a BOR of CR, PR, or stable disease (SD).
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=38 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
36 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From the signing of informed consent until 30 days (+/- 3 days) after the last dose of study drug (up to approximately 12 months).Population: The safety analysis set comprised all patients who received at least one dose of ompenaclid or matching placebo (N=75). One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria.
Percentage of patients with treatment-emergent AEs (TEAE).
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=37 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Frequency of Adverse Events (AEs)
|
37 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At Cycle 1 day 15 and Cycle 2 day 15 (each cycle is 28 days in length)Population: Ompenaclid pharmacokinetics was assessed in ompenaclid arm only.
Steady state concentration of ompenaclid.
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=33 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Pharmacokinetics of Ompenaclid
C1D15
|
2686 Mean concentration (ng/mL)
Standard Deviation 2372
|
—
|
|
Pharmacokinetics of Ompenaclid
C2D15
|
2909 Mean concentration (ng/mL)
Standard Deviation 2333
|
—
|
SECONDARY outcome
Timeframe: At baselineCreatine kinase B (CKB) levels identified in baseline tumor tissue samples analyzed retrospectively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.Population: All randomized participants (ITT: N=38 in each group)
PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease (PD) per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first. The proportions of participants who have not experienced PFS events (radiological disease progression or death) at 6 months and 9 months are presented.
Outcome measures
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=38 Participants
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
Placebo + FOLFIRI + Bevacizumab
n=38 Participants
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
|
|---|---|---|
|
Progression-Free Survival (PFS) Rate at 6 and 9 Months
PFS rate at 6 months
|
63.4 Percentage of participants
Interval 49.4708 to 77.3846
|
62.8 Percentage of participants
Interval 49.1564 to 76.3769
|
|
Progression-Free Survival (PFS) Rate at 6 and 9 Months
PFS rate at 9 months
|
48.4 Percentage of participants
Interval 33.1111 to 63.6604
|
46.2 Percentage of participants
Interval 30.615 to 61.6889
|
Adverse Events
Ompenaclid + FOLFIRI + Bevacizumab
Serious events: 12 serious events
Other events: 37 other events
Deaths: 4 deaths
Placebo + FOLFIRI + Bevacizumab
Serious events: 9 serious events
Other events: 38 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=37 participants at risk
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Ompenaclid: Ompenaclid (RGX-202-01)
Bevacizumab: Bevacizumab
FOLFIRI regimen: FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle)
|
Placebo + FOLFIRI + Bevacizumab
n=38 participants at risk
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Placebo: Placebo
Bevacizumab: Bevacizumab
FOLFIRI regimen: FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle)
|
|---|---|---|
|
Infections and infestations
Anal abscess
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Device related infection
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Fourier's gangrene
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Post operative wound infection
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Sepsis
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Staphylococcal infection
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Cardiac disorders
Atrial thrombosis
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Rectal perforation
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Pyrexia
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Asthenia
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
General physical health deterioration
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Influenza like illness
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary tumour thrombotic microangiopathy
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
Other adverse events
| Measure |
Ompenaclid + FOLFIRI + Bevacizumab
n=37 participants at risk
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Ompenaclid: Ompenaclid (RGX-202-01)
Bevacizumab: Bevacizumab
FOLFIRI regimen: FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle)
|
Placebo + FOLFIRI + Bevacizumab
n=38 participants at risk
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Placebo: Placebo
Bevacizumab: Bevacizumab
FOLFIRI regimen: FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
64.9%
24/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
84.2%
32/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Nausea
|
73.0%
27/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
47.4%
18/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Vomiting
|
59.5%
22/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
36.8%
14/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Stomatitis
|
37.8%
14/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
34.2%
13/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Constipation
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
26.3%
10/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
23.7%
9/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Proctalgia
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Dry mouth
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Dysphagia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Haematochezia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Asthenia
|
48.6%
18/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
42.1%
16/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Fatigue
|
21.6%
8/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
28.9%
11/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Pyrexia
|
16.2%
6/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
10.5%
4/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Influenza like illness
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
General disorders
Oedema peripheral
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Respiratory tract infection
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
13.2%
5/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
COVID-19
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Oral herpes
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Influenza
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.5%
15/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
47.4%
18/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
10.5%
4/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.7%
11/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
31.6%
12/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
18.4%
7/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
10.5%
4/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
32.4%
12/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
21.1%
8/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
13.2%
5/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.9%
7/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
21.1%
8/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Dysgeusia
|
18.9%
7/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
13.2%
5/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Headache
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Dizziness
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Migraine
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Nervous system disorders
Syncope
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Investigations
Neutrophil count decreased
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
13.2%
5/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Investigations
Aspartate aminotransferase increased
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
10.5%
4/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
10.5%
4/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Investigations
Weight decreased
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
7.9%
3/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.7%
1/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
13.2%
5/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Vascular disorders
Hypertension
|
13.5%
5/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
18.4%
7/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Vascular disorders
Hypotension
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Vascular disorders
Flushing
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Psychiatric disorders
Insomnia
|
10.8%
4/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
5.3%
2/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Eye disorders
Dry eye
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Renal and urinary disorders
Dysuria
|
8.1%
3/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Ear and labyrinth disorders
Vertigo
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
2.6%
1/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.4%
2/37 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
0.00%
0/38 • All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria. All-Cause Mortality was assessed in all randomized participants. Serious and Other Adverse Events were assessed in the safety analysis set, which comprised all patients who received at least one dose of ompenaclid or matching placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure by PI after multi-center publication by Sponsor within 12 months and any proposed publication requires review by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER