Trial Outcomes & Findings for A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) (NCT NCT03401112)
NCT ID: NCT03401112
Last Updated: 2025-05-15
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An SAE was defined as any AE that resulted in 1 or more of the following outcomes: death, required or prolonged hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, or other medically important event. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Day 1 (after dosing) through up to Week 24
Results posted on
2025-05-15
Participant Flow
Study participants were enrolled at 13 sites in 2 countries (United Kingdom and United States).
Participant milestones
| Measure |
IMR-687 50 mg/100 mg (Without HU)
A starting dose of IMR-687 50 milligrams (mg) with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily hydroxyurea (HU).
|
IMR-687 100 mg/200 mg (Without HU)
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
26
|
22
|
27
|
10
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
12
|
26
|
20
|
25
|
10
|
|
Overall Study
COMPLETED
|
10
|
19
|
11
|
21
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
11
|
6
|
0
|
Reasons for withdrawal
| Measure |
IMR-687 50 mg/100 mg (Without HU)
A starting dose of IMR-687 50 milligrams (mg) with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily hydroxyurea (HU).
|
IMR-687 100 mg/200 mg (Without HU)
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Noncompliance
|
1
|
2
|
3
|
0
|
0
|
|
Overall Study
Did not Meet Inclusion Criteria
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Study was Terminated by Sponsor
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Day 1 Assessment not Done
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Not Dosed
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Missed Clinical Visit
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Missed Doses
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Baseline characteristics by cohort
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=26 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=20 Participants
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=25 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
n=10 Participants
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
28.8 years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
32.8 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
86 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown Ethnicity
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after dosing) through up to Week 24Population: All participants who had received any amount of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An SAE was defined as any AE that resulted in 1 or more of the following outcomes: death, required or prolonged hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, or other medically important event. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=26 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=20 Participants
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=25 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
n=10 Participants
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
n=63 Participants
All participants who received IMR-687.
|
All Placebo
n=30 Participants
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)
TEAEs
|
12 Participants
|
24 Participants
|
18 Participants
|
23 Participants
|
10 Participants
|
59 Participants
|
28 Participants
|
|
Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)
SAEs
|
4 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Week 25Population: PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.
For PK assessments of participants who did not concomitantly receive HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 25) assessments are presented.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=13 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Of Participants Who Did Not Concomitantly Receive HU: Maximum Plasma Concentration (Cmax) Of IMR-687
Day 1: Single Dose
|
512 ng/mL
Geometric Coefficient of Variation 30.1
|
1130 ng/mL
Geometric Coefficient of Variation 33.5
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Of Participants Who Did Not Concomitantly Receive HU: Maximum Plasma Concentration (Cmax) Of IMR-687
Week 25: Steady State
|
1290 ng/mL
Geometric Coefficient of Variation 36.4
|
2180 ng/mL
Geometric Coefficient of Variation 24.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Week 25Population: PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.
For PK assessments of participants who did not concomitantly receive HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 25) assessments are presented.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=11 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=10 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
PK Of Participants Who Did Not Concomitantly Receive HU: Area Under The Concentration-time Curve (AUC) From Time 0 To 24 Hours Postdose (AUC0-24h) Of IMR-687
Day 1: Single Dose
|
2850 h*ng/mL
Geometric Coefficient of Variation 12.5
|
6590 h*ng/mL
Geometric Coefficient of Variation 17.7
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Did Not Concomitantly Receive HU: Area Under The Concentration-time Curve (AUC) From Time 0 To 24 Hours Postdose (AUC0-24h) Of IMR-687
Week 25: Steady State
|
8420 h*ng/mL
Geometric Coefficient of Variation 24.1
|
15000 h*ng/mL
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Week 17Population: PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.
For PK assessments of participants who concomitantly received HU, serial blood samples for IMR-687 PK were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 17) assessments are presented.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=13 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
PK Of Participants Who Concomitantly Received HU: Cmax Of IMR-687
Day 1: Single Dose
|
657 ng/mL
Geometric Coefficient of Variation 24.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Concomitantly Received HU: Cmax Of IMR-687
Week 17: Steady State
|
1370 ng/mL
Geometric Coefficient of Variation 18.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Week 17Population: PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.
For PK assessments of participants who concomitantly received HU, serial blood samples for IMR-687 plasma concentrations were drawn predose at 0.5, 1, 1.5, 2, 4, 6, and 8 hours after administration of study drug; and at 24 hours after administration of study drug. Day 1 (single-dose) and steady-state (Week 17) assessments are presented.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
PK Of Participants Who Concomitantly Received HU: AUC0-24h Of IMR-687
Day 1: Single Dose
|
3090 h*ng/mL
Geometric Coefficient of Variation 34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Concomitantly Received HU: AUC0-24h Of IMR-687
Week 17: Steady State
|
7300 h*ng/mL
Geometric Coefficient of Variation 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (1 and 2) and Week 17Population: PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.
For PK assessments of participants who concomitantly received HU, serial blood samples for HU PK were drawn predose and at 0.5, 1, 1.5, 3, 6, 8, and 10 hours after self-administration of the prescribed dose of HU. HU in the presence (end of treatment \[EOT\]: Week 17) or absence of IMR-687 (Baselines 1 and 2) are presented. HU concentration data were not sorted with respect to HU dose.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=14 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=6 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
PK Of Participants Who Concomitantly Received HU: Cmax Of HU
Baseline 1
|
25.3 μg/mL
Geometric Coefficient of Variation 36.7
|
20.6 μg/mL
Geometric Coefficient of Variation 87.8
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Concomitantly Received HU: Cmax Of HU
Baseline 2
|
24.8 μg/mL
Geometric Coefficient of Variation 38.1
|
25.4 μg/mL
Geometric Coefficient of Variation 98.6
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Concomitantly Received HU: Cmax Of HU
Week 17
|
24.5 μg/mL
Geometric Coefficient of Variation 55.2
|
20.5 μg/mL
Geometric Coefficient of Variation 127
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (1 and 2) and Week 17Population: PK Analysis population consisted of all participants with sufficient sampling for PK parameter evaluation.
For PK assessments of participants who concomitantly received HU, serial blood samples for HU PK were drawn predose and at 0.5, 1, 1.5, 3, 6, 8, and 10 hours after self-administration of the prescribed dose of HU. HU in the presence (EOT: Week 17) or absence of IMR-687 (Baselines 1 and 2) are presented. HU concentration data were not sorted with respect to HU dose.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=5 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
PK Of Participants Who Concomitantly Received HU: AUC0-24h Of HU
Baseline 1
|
99.2 h*μg/mL
Geometric Coefficient of Variation 32.4
|
113 h*μg/mL
Geometric Coefficient of Variation 87.7
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Concomitantly Received HU: AUC0-24h Of HU
Baseline 2
|
103 h*μg/mL
Geometric Coefficient of Variation 30.7
|
129 h*μg/mL
Geometric Coefficient of Variation 71.7
|
—
|
—
|
—
|
—
|
—
|
|
PK Of Participants Who Concomitantly Received HU: AUC0-24h Of HU
Week 17
|
122 h*μg/mL
Geometric Coefficient of Variation 23.0
|
91.4 h*μg/mL
Geometric Coefficient of Variation 127
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, EOT (Week 25 for participants without HU and Weeks 17 or 25 for participants with HU)Population: All participants who had samples for PD analysis sufficient to obtain at least 1 valid PD observation, without protocol deviations or events that would be expected to affect the PD analysis.
Absolute least squares (LS) mean change from baseline at EOT is presented. Change from baseline in pharmacodynamic (PD) biomarkers was analyzed using mixed models for repeated measures with covariate of treatment, visit, treatment-by-visit interaction, and baseline value.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=7 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=13 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=20 Participants
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=7 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
n=5 Participants
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
n=1 Participants
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline In F-Cells
|
3.97 percentage of F-cells
Standard Error 4.07
|
5.66 percentage of F-cells
Standard Error 2.87
|
4.81 percentage of F-cells
Standard Error 2.48
|
-6.00 percentage of F-cells
Standard Error 3.77
|
-2.49 percentage of F-cells
Standard Error 6.00
|
7.38 percentage of F-cells
Standard Error 15.54
|
—
|
POST_HOC outcome
Timeframe: Day 1 (after dosing) through up to Week 24Population: All participants who had received any amount of study drug.
VOCs include the events of acute painful crisis and acute chest symptoms (includes fever, cough, sputum production, shortness of breath, tachypnea, hypoxia, and chest pain).
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=26 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=20 Participants
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=25 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
n=10 Participants
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
n=63 Participants
All participants who received IMR-687.
|
All Placebo
n=30 Participants
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Number Of Participants With Vaso-occlusive Crisis (VOCs)
|
6 Participants
|
14 Participants
|
14 Participants
|
10 Participants
|
7 Participants
|
30 Participants
|
21 Participants
|
POST_HOC outcome
Timeframe: Day 1 (after dosing) through up to Week 24Population: Pooled data from the IMR-687 dose groups (IMR-687 50mg/100 mg \[Without HU\]+ IMR-687 100mg/200 mg \[Without HU\] + IMR-687 50mg/100 mg \[With HU\]) and pooled data from the placebo arms (With and without HU) were used to provide a larger sample size for the analysis of time to 1st event.
VOCs include the events of acute painful crisis and acute chest symptoms (includes fever, cough, sputum production, shortness of breath, tachypnea, hypoxia, and chest pain). Time to first VOC event was assessed by Kaplan Meier analysis. For this analysis, HU and without HU population groups were pooled for IMR-687 and placebo. In addition, pooled IMR-687 (all doses) are presented.
Outcome measures
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=37 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=26 Participants
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=63 Participants
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=30 Participants
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
All participants who received IMR-687.
|
All Placebo
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Time To First VOC Event
|
NA days
Interval 60.0 to
The median and upper confidence limit were non-estimable due to insufficient number of participants with an event to estimate variability and build a confidence interval.
|
139.00 days
Interval 35.0 to
The upper confidence limit was non-estimable due to insufficient number of participants with an event to estimate variability and build a confidence interval.
|
169.00 days
Interval 80.0 to
The upper confidence limit was non-estimable due to insufficient number of participants with an event to estimate variability and build a confidence interval.
|
87.00 days
Interval 26.0 to 167.0
|
—
|
—
|
—
|
Adverse Events
IMR-687 50 mg/100 mg (Without HU)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
IMR-687 100 mg/200 mg (Without HU)
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo (Without HU)
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
IMR-687 50 mg/100 mg (With HU)
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo (With HU)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
All IMR-687
Serious events: 16 serious events
Other events: 57 other events
Deaths: 0 deaths
All Placebo
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 participants at risk
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=26 participants at risk
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=20 participants at risk
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=25 participants at risk
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
n=10 participants at risk
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
n=63 participants at risk
All participants who received IMR-687.
|
All Placebo
n=30 participants at risk
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
25.0%
3/12 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
26.9%
7/26 • Number of events 8 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
35.0%
7/20 • Number of events 11 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
12.0%
3/25 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
30.0%
3/10 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.6%
13/63 • Number of events 15 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
33.3%
10/30 • Number of events 14 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/30 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.8%
1/26 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/30 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Hepatobiliary disorders
Hepatic lesion
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/30 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/30 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
12.5%
1/8 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/17 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/15 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/9 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
2.5%
1/40 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/21 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/30 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/8 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/17 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
1/15 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/9 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
2.5%
1/40 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/21 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Skin and subcutaneous tissue disorders
Rash generalise
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/63 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.3%
1/30 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
Other adverse events
| Measure |
IMR-687 50 mg/100 mg (Without HU)
n=12 participants at risk
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were not receiving daily HU.
|
IMR-687 100 mg/200 mg (Without HU)
n=26 participants at risk
A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants who were not receiving daily HU.
|
Placebo (Without HU)
n=20 participants at risk
Matching placebo was administered to participants who were not receiving daily HU.
|
IMR-687 50 mg/100 mg (With HU)
n=25 participants at risk
A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
Placebo (With HU)
n=10 participants at risk
Matching placebo was administered to participants who were receiving daily HU. HU doses ranged from 500 to 2000 mg.
|
All IMR-687
n=63 participants at risk
All participants who received IMR-687.
|
All Placebo
n=30 participants at risk
All participants who received placebo.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
41.7%
5/12 • Number of events 15 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
34.6%
9/26 • Number of events 15 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
45.0%
9/20 • Number of events 14 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
40.0%
10/25 • Number of events 14 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
60.0%
6/10 • Number of events 23 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
38.1%
24/63 • Number of events 44 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
50.0%
15/30 • Number of events 37 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
30.8%
8/26 • Number of events 14 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
16.0%
4/25 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
50.0%
5/10 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
22.2%
14/63 • Number of events 21 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
16.7%
5/30 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
11.5%
3/26 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.9%
5/63 • Number of events 7 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.3%
1/30 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.9%
5/63 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/30 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.9%
5/63 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.3%
1/30 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.8%
3/63 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
16.0%
4/25 • Number of events 6 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.0%
2/10 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
11.1%
7/63 • Number of events 9 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
13.3%
4/30 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
General disorders
Influenza like illness
|
16.7%
2/12 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
9.5%
6/63 • Number of events 10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
General disorders
Pain
|
16.7%
2/12 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.8%
1/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.3%
4/63 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.3%
1/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/63 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Hepatobiliary disorders
Ocular icterus
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
16.0%
4/25 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
11.1%
7/63 • Number of events 7 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.3%
1/30 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/20 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.0%
2/10 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
3/12 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.8%
1/26 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.0%
2/10 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
9.5%
6/63 • Number of events 9 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
13.3%
4/30 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.9%
5/63 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
23.1%
6/26 • Number of events 7 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.0%
2/10 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
11.1%
7/63 • Number of events 8 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
13.3%
4/30 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
15.4%
4/26 • Number of events 5 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
9.5%
6/63 • Number of events 7 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.7%
2/26 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.0%
2/10 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
7.9%
5/63 • Number of events 6 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
13.3%
4/30 • Number of events 4 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.8%
1/26 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.8%
3/63 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
30.8%
8/26 • Number of events 11 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
20.0%
4/20 • Number of events 6 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
48.0%
12/25 • Number of events 18 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
40.0%
4/10 • Number of events 6 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
34.9%
22/63 • Number of events 31 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
26.7%
8/30 • Number of events 12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
8.0%
2/25 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.2%
2/63 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/63 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.8%
1/26 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.0%
1/25 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
4.8%
3/63 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/63 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
3/30 • Number of events 3 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/63 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/26 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
2/20 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/10 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/63 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
3.8%
1/26 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
5.0%
1/20 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
0.00%
0/25 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
10.0%
1/10 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
1.6%
1/63 • Number of events 1 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
6.7%
2/30 • Number of events 2 • Day 1 (after dosing) through up to Week 24
Adverse event data are presented for each of the following IMR-687 groups which included a brief dose escalation: IMR-687 50mg/100 mg \[Without HU\], IMR-687 100mg/200 mg \[Without HU\], IMR-687 50mg/100 mg \[With HU\] and for each placebo arm. Data are not available by dose escalation within arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place