Trial Outcomes & Findings for A Study of IMR-687 in Subjects With Beta Thalassemia (NCT NCT04411082)
NCT ID: NCT04411082
Last Updated: 2025-05-15
Results Overview
Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Baseline to Week 40
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
TDT High Dose
TDT High dose
|
TDT Low Dose
TDT Low dose
|
TDT Placebo
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
25
|
20
|
24
|
12
|
12
|
|
Overall Study
COMPLETED
|
18
|
16
|
16
|
10
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
4
|
14
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of IMR-687 in Subjects With Beta Thalassemia
Baseline characteristics by cohort
| Measure |
TDT High Dose
n=29 Participants
TDT High dose
|
TDT Low Dose
n=25 Participants
TDT Low dose
|
TDT Placebo
n=20 Participants
TDT Placebo
|
NTDT High Dose
n=24 Participants
NTDT High dose
|
NTDT Low Dose
n=12 Participants
NTDT Low dose
|
NTDT Placebo
n=12 Participants
NTDT Placebo
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.7 Years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
30.0 Years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
31.3 Years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
34.1 Years
STANDARD_DEVIATION 12.64 • n=4 Participants
|
28.5 Years
STANDARD_DEVIATION 8.21 • n=21 Participants
|
36.0 Years
STANDARD_DEVIATION 9.56 • n=8 Participants
|
31.9 Years
STANDARD_DEVIATION 10.69 • n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
63 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
80 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
Malaysia
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Region of Enrollment
Greece
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Region of Enrollment
Lebanon
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
Turkey
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Region of Enrollment
Morocco
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
Georgia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
Tunisia
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
BMI
|
22.900 kg/m2
STANDARD_DEVIATION 3.2252 • n=5 Participants
|
21.252 kg/m2
STANDARD_DEVIATION 2.2874 • n=7 Participants
|
22.699 kg/m2
STANDARD_DEVIATION 2.9968 • n=5 Participants
|
22.031 kg/m2
STANDARD_DEVIATION 3.5415 • n=4 Participants
|
21.1320 kg/m2
STANDARD_DEVIATION 3.5047 • n=21 Participants
|
21.9120 kg/m2
STANDARD_DEVIATION 3.5638 • n=8 Participants
|
22.0873 kg/m2
STANDARD_DEVIATION 3.1573 • n=8 Participants
|
|
Serum Ferritin
|
1724.4 micrograms per liter
STANDARD_DEVIATION 1857.66 • n=5 Participants
|
3449.1 micrograms per liter
STANDARD_DEVIATION 5093.24 • n=7 Participants
|
1793.3 micrograms per liter
STANDARD_DEVIATION 1844.72 • n=5 Participants
|
981.4 micrograms per liter
STANDARD_DEVIATION 951.29 • n=4 Participants
|
945.8 micrograms per liter
STANDARD_DEVIATION 962.09 • n=21 Participants
|
447.8 micrograms per liter
STANDARD_DEVIATION 222.32 • n=8 Participants
|
1726.69 micrograms per liter
STANDARD_DEVIATION 2740.18 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 40Population: Safety Analysis set
Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events
Outcome measures
| Measure |
TDT High Dose
n=29 Participants
TDT High dose
|
TDT Low Dose
n=25 Participants
TDT Low dose
|
TDT Placebo
n=20 Participants
TDT Placebo
|
NTDT High Dose
n=24 Participants
NTDT High dose
|
NTDT Low Dose
n=12 Participants
NTDT Low dose
|
NTDT Placebo
n=12 Participants
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
IMR-687 Safety and Tolerability
Treatment emergent Adverse Events
|
25 Participants
|
22 Participants
|
15 Participants
|
18 Participants
|
12 Participants
|
6 Participants
|
|
IMR-687 Safety and Tolerability
Treatment emergent Adverse Event related to study drug
|
19 Participants
|
15 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
4 Participants
|
|
IMR-687 Safety and Tolerability
Grade 3 or greater treatment emergent Adverse Event
|
4 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Per Protocol Analysis
Proportion of patients with ≥33% hematological improvement (as measured by reduced transfusion burden) from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)
Outcome measures
| Measure |
TDT High Dose
n=21 Participants
TDT High dose
|
TDT Low Dose
n=18 Participants
TDT Low dose
|
TDT Placebo
n=18 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Per protocol analysis
Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 12 to Week 24 in the absence of transfusions.
Outcome measures
| Measure |
TDT High Dose
n=15 Participants
TDT High dose
|
TDT Low Dose
n=10 Participants
TDT Low dose
|
TDT Placebo
n=10 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Per Protocol Analysis
Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 12 to Week 24 in absence of transfusions
Outcome measures
| Measure |
TDT High Dose
n=11 Participants
TDT High dose
|
TDT Low Dose
n=5 Participants
TDT Low dose
|
TDT Placebo
n=8 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Per Protocol Analysis
Proportion of patients with ≥33% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)
Outcome measures
| Measure |
TDT High Dose
n=16 Participants
TDT High dose
|
TDT Low Dose
n=13 Participants
TDT Low dose
|
TDT Placebo
n=15 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Per Protocol Analysis
Proportion of patients with ≥50% hematological improvement from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)
Outcome measures
| Measure |
TDT High Dose
n=21 Participants
TDT High dose
|
TDT Low Dose
n=18 Participants
TDT Low dose
|
TDT Placebo
n=18 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Per Protocol Analysis
Proportion of patients with ≥50% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)
Outcome measures
| Measure |
TDT High Dose
n=16 Participants
TDT High dose
|
TDT Low Dose
n=13 Participants
TDT Low dose
|
TDT Placebo
n=15 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Per Protocol Analysis
Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 24 to Week 36 in the absence of transfusions.
Outcome measures
| Measure |
TDT High Dose
n=12 Participants
TDT High dose
|
TDT Low Dose
n=9 Participants
TDT Low dose
|
TDT Placebo
n=8 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Per Protocol Analysis
Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 24 to Week 36 in absence of transfusions
Outcome measures
| Measure |
TDT High Dose
n=8 Participants
TDT High dose
|
TDT Low Dose
n=6 Participants
TDT Low dose
|
TDT Placebo
n=7 Participants
TDT Placebo
|
NTDT High Dose
NTDT High dose
|
NTDT Low Dose
NTDT Low dose
|
NTDT Placebo
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
TDT High Dose
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
TDT Low Dose
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
TDT Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
NTDT High Dose
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
NTDT Low Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
NTDT Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDT High Dose
n=29 participants at risk
TDT High dose
|
TDT Low Dose
n=25 participants at risk
TDT Low dose
|
TDT Placebo
n=20 participants at risk
TDT Placebo
|
NTDT High Dose
n=24 participants at risk
NTDT High dose
|
NTDT Low Dose
n=12 participants at risk
NTDT Low dose
|
NTDT Placebo
n=12 participants at risk
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Carbon Monoxide Poisoning
|
0.00%
0/29 • 10 months
|
0.00%
0/25 • 10 months
|
5.0%
1/20 • Number of events 1 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Infections and infestations
COVID19
|
0.00%
0/29 • 10 months
|
8.0%
2/25 • Number of events 2 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Infections and infestations
Liver abscess
|
0.00%
0/29 • 10 months
|
4.0%
1/25 • Number of events 1 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • 10 months
|
4.0%
1/25 • Number of events 1 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
1/29 • Number of events 1 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Number of events 1 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
3.4%
1/29 • Number of events 1 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/29 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
4.2%
1/24 • Number of events 1 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/29 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
4.2%
1/24 • Number of events 1 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/29 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
4.2%
1/24 • Number of events 1 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
Other adverse events
| Measure |
TDT High Dose
n=29 participants at risk
TDT High dose
|
TDT Low Dose
n=25 participants at risk
TDT Low dose
|
TDT Placebo
n=20 participants at risk
TDT Placebo
|
NTDT High Dose
n=24 participants at risk
NTDT High dose
|
NTDT Low Dose
n=12 participants at risk
NTDT Low dose
|
NTDT Placebo
n=12 participants at risk
NTDT Placebo
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
34.5%
10/29 • 10 months
|
40.0%
10/25 • 10 months
|
35.0%
7/20 • 10 months
|
20.8%
5/24 • 10 months
|
16.7%
2/12 • 10 months
|
16.7%
2/12 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
37.9%
11/29 • 10 months
|
24.0%
6/25 • 10 months
|
5.0%
1/20 • 10 months
|
20.8%
5/24 • 10 months
|
8.3%
1/12 • 10 months
|
8.3%
1/12 • 10 months
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • 10 months
|
20.0%
5/25 • 10 months
|
10.0%
2/20 • 10 months
|
4.2%
1/24 • 10 months
|
0.00%
0/12 • 10 months
|
8.3%
1/12 • 10 months
|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
4/29 • 10 months
|
4.0%
1/25 • 10 months
|
10.0%
2/20 • 10 months
|
4.2%
1/24 • 10 months
|
16.7%
2/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Infections and infestations
Gastroenteritis
|
10.3%
3/29 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.9%
2/29 • 10 months
|
0.00%
0/25 • 10 months
|
5.0%
1/20 • 10 months
|
0.00%
0/24 • 10 months
|
0.00%
0/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.9%
2/29 • 10 months
|
8.0%
2/25 • 10 months
|
0.00%
0/20 • 10 months
|
0.00%
0/24 • 10 months
|
8.3%
1/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.9%
2/29 • 10 months
|
4.0%
1/25 • 10 months
|
5.0%
1/20 • 10 months
|
12.5%
3/24 • 10 months
|
25.0%
3/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • 10 months
|
0.00%
0/25 • 10 months
|
10.0%
2/20 • 10 months
|
4.2%
1/24 • 10 months
|
8.3%
1/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
General disorders
Fatigue
|
3.4%
1/29 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
12.5%
3/24 • 10 months
|
16.7%
2/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Gastrointestinal disorders
Vomitting
|
3.4%
1/29 • 10 months
|
0.00%
0/25 • 10 months
|
0.00%
0/20 • 10 months
|
12.5%
3/24 • 10 months
|
16.7%
2/12 • 10 months
|
0.00%
0/12 • 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/29 • 10 months
|
4.0%
1/25 • 10 months
|
5.0%
1/20 • 10 months
|
8.3%
2/24 • 10 months
|
16.7%
2/12 • 10 months
|
8.3%
1/12 • 10 months
|
|
Infections and infestations
COVID19
|
3.4%
1/29 • 10 months
|
12.0%
3/25 • 10 months
|
0.00%
0/20 • 10 months
|
12.5%
3/24 • 10 months
|
0.00%
0/12 • 10 months
|
16.7%
2/12 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place