Trial Outcomes & Findings for Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease (NCT NCT02496884)
NCT ID: NCT02496884
Last Updated: 2020-11-24
Results Overview
A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state. Relationship of TEAEs to study drug is assessed by the investigator. Clinically significant changes from baseline in clinical laboratory evaluations, neurological examinations, and electrocardiograms are reported as TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
Baseline up to 30 days after last dose, up to 25 months
Results posted on
2020-11-24
Participant Flow
A total of 56 participants who met all inclusion and no exclusion criteria were randomized to treatment in four countries: Bulgaria, Romania, Spain, and the United States.
Eligible participants were randomized 2:1 to receive either DS-5565 7.5 mg QD or placebo for participants with CrCl 15 to 29 mL/min, or 2:1 to receive treatment with DS-5565 7.5 mg BID or placebo for participants with CrCl 30 to 59 mL/min over a 13-week double-blind treatment period.
Participant milestones
| Measure |
M-CKD Placebo
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
34
|
1
|
4
|
|
Overall Study
Safety Analysis Set
|
17
|
34
|
1
|
4
|
|
Overall Study
Modified Intent to Treat Set (mITT)
|
17
|
34
|
1
|
4
|
|
Overall Study
Pharmacokinetic (PK) Analysis Set
|
0
|
33
|
0
|
4
|
|
Overall Study
Completed Treatment Per Protocol
|
16
|
27
|
1
|
3
|
|
Overall Study
COMPLETED
|
15
|
31
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
M-CKD Placebo
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Overall Study
Counted twice as enrolled
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
Baseline Characteristics
Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
M-CKD Placebo
n=17 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 13.92 • n=7 Participants
|
53.0 years
n=5 Participants
|
74.0 years
STANDARD_DEVIATION 12.25 • n=4 Participants
|
67.3 years
STANDARD_DEVIATION 13.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Baseline Average Daily Pain Score (ADPS)
ADPS less than 7
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Baseline Average Daily Pain Score (ADPS)
ADPS 7 or more
|
9 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Baseline Average Daily Pain Score (ADPS)
|
6.99 units on a scale
STANDARD_DEVIATION 1.35 • n=5 Participants
|
7.21 units on a scale
STANDARD_DEVIATION 0.96 • n=7 Participants
|
5.70 units on a scale
n=5 Participants
|
6.53 units on a scale
STANDARD_DEVIATION 0.82 • n=4 Participants
|
7.07 units on a scale
STANDARD_DEVIATION 1.09 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 25 monthsPopulation: Safety events were assessed in the Safety Analysis Set.
A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state. Relationship of TEAEs to study drug is assessed by the investigator. Clinically significant changes from baseline in clinical laboratory evaluations, neurological examinations, and electrocardiograms are reported as TEAEs.
Outcome measures
| Measure |
M-CKD Placebo
n=17 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Serious TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
At least 1 TEAE
|
8 Participants
|
16 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Drug-related TEAEs
|
1 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Drug-related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening up to Week 13 postdosePopulation: The C-SSRS score was assessed in the Safety Analysis Set.
The C-SSRS is described as a scale developed at Columbia University that has 2-6 questions each in categories of Suicidal Ideation, Intensity of Ideation, Suicidal Behavior, and Actual Attempts. Four constructs were measured. Severity of Suicidal ideation is rated on a 5-point ordinal scale. Intensity of ideation is comprised of 5 items (frequency, duration, controllability, deterrents, and reason for ideation), each rated on a 5-point ordinal scale. Suicidal behavior is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. Lethality, assesses actual attempts; actual lethality is rated on a 6-point ordinal scale, and if actual lethality is 0, potential lethality of attempts is rated on a 3-point ordinal scale.The higher the C-SSRS score, the higher the suicide risk (ie. worse outcome).
Outcome measures
| Measure |
M-CKD Placebo
n=17 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Patients Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patients Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patients Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13 postdosePopulation: Average daily pain scores were assessed in the modified Intent-to-Treat (mITT) Analysis Set.
Each day participants will rate their worst pain over the last 24 hours on a scale from 0-10, where 0=no pain and 10=worst pain imaginable. Each week individual pain scores will be averaged, and the mean weekly score for the treatment group will be calculated. Higher ADPS scores indicate worse outcome.
Outcome measures
| Measure |
M-CKD Placebo
n=17 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Baseline
|
6.99 units on a scale
Standard Deviation 1.35
|
7.21 units on a scale
Standard Deviation 0.96
|
5.70 units on a scale
|
6.53 units on a scale
Standard Deviation 0.82
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 1
|
6.26 units on a scale
Standard Deviation 1.53
|
6.10 units on a scale
Standard Deviation 1.63
|
2.0 units on a scale
|
6.88 units on a scale
Standard Deviation 0.15
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 2
|
6.03 units on a scale
Standard Deviation 1.68
|
5.73 units on a scale
Standard Deviation 2.06
|
1.70 units on a scale
|
6.60 units on a scale
Standard Deviation 0.80
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 3
|
5.77 units on a scale
Standard Deviation 1.72
|
5.55 units on a scale
Standard Deviation 1.94
|
1.70 units on a scale
|
6.80 units on a scale
Standard Deviation 0.40
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 4
|
5.41 units on a scale
Standard Deviation 1.91
|
5.43 units on a scale
Standard Deviation 1.99
|
1.30 units on a scale
|
6.75 units on a scale
Standard Deviation 0.50
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 5
|
5.45 units on a scale
Standard Deviation 1.65
|
5.46 units on a scale
Standard Deviation 2.08
|
0.70 units on a scale
|
6.90 units on a scale
Standard Deviation 0.99
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 6
|
5.16 units on a scale
Standard Deviation 1.75
|
5.16 units on a scale
Standard Deviation 2.18
|
1.4 units on a scale
|
6.43 units on a scale
Standard Deviation 1.91
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 7
|
5.03 units on a scale
Standard Deviation 2.10
|
5.09 units on a scale
Standard Deviation 2.14
|
1.20 units on a scale
|
6.67 units on a scale
Standard Deviation 1.53
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 8
|
5.15 units on a scale
Standard Deviation 2.03
|
5.04 units on a scale
Standard Deviation 2.23
|
1.00 units on a scale
|
6.73 units on a scale
Standard Deviation 1.52
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 9
|
5.09 units on a scale
Standard Deviation 1.82
|
4.81 units on a scale
Standard Deviation 2.24
|
1.00 units on a scale
|
6.47 units on a scale
Standard Deviation 1.91
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 10
|
4.86 units on a scale
Standard Deviation 2.06
|
4.97 units on a scale
Standard Deviation 2.20
|
0.90 units on a scale
|
6.53 units on a scale
Standard Deviation 1.75
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 11
|
4.28 units on a scale
Standard Deviation 1.99
|
4.80 units on a scale
Standard Deviation 2.31
|
0.70 units on a scale
|
6.73 units on a scale
Standard Deviation 1.12
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 12
|
4.17 units on a scale
Standard Deviation 2.16
|
4.69 units on a scale
Standard Deviation 2.20
|
0.80 units on a scale
|
6.63 units on a scale
Standard Deviation 2.27
|
|
Mean Weekly Average of Individual Daily Pain Scores (ADPS)
Week 13
|
4.28 units on a scale
Standard Deviation 2.45
|
4.15 units on a scale
Standard Deviation 1.84
|
1.00 units on a scale
|
6.80 units on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Week 13 postdosePopulation: Patient Global Impression of Change (PGIC) scores were assessed in the modified Intent-to-Treat (mITT) Analysis Set.
The PGIC is a validated outcome measure for treatment of pain in the acute pain setting. At the end of treatment, participants will rate their overall status on a scale of 1-7, where 1=very much improved and 7=very much worse using the standard PGIC questionnaire. Higher scores indicate worse outcome.
Outcome measures
| Measure |
M-CKD Placebo
n=17 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 Participants
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 Participants
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Number of Participants With Different Scale Ranges of the Patient Global Impression of Change (PGIC) Scale at Week 13
Score 1-3; Improved
|
12 Participants
|
20 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Different Scale Ranges of the Patient Global Impression of Change (PGIC) Scale at Week 13
Score 4; No change
|
3 Participants
|
8 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Different Scale Ranges of the Patient Global Impression of Change (PGIC) Scale at Week 13
Score 5-7; Worsened
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Different Scale Ranges of the Patient Global Impression of Change (PGIC) Scale at Week 13
Missing
|
1 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
M-CKD Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
M-CKD DS-5565 7.5 mg BID
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
S-CKD Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S-CKD DS-5565 7.5 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
M-CKD Placebo
n=17 participants at risk
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 participants at risk
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 participants at risk
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 participants at risk
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
2.9%
1/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
Other adverse events
| Measure |
M-CKD Placebo
n=17 participants at risk
Patients with moderate chronic kidney disease (M-CKD) randomized to receive placebo twice daily (BID) during the treatment period.
|
M-CKD DS-5565 7.5 mg BID
n=34 participants at risk
Patients with moderate chronic kidney disease (M-CKD) randomized to receive DS-5565 7.5 mg BID during the treatment period.
|
S-CKD Placebo
n=1 participants at risk
Patients with severe chronic kidney disease (S-CKD) randomized to receive placebo once daily (QD) during the treatment period.
|
S-CKD DS-5565 7.5 mg QD
n=4 participants at risk
Patients with severe chronic kidney disease (S-CKD) randomized to receive a DS-5565 7.5 mg tablet once per day (QD).
|
|---|---|---|---|---|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
5.9%
2/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
5.9%
2/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Investigations
Weight increased
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
5.9%
2/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Investigations
Creatinine renal decreased
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
8.8%
3/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
5.9%
2/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
2.9%
1/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
5.9%
2/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
17.6%
3/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
8.8%
3/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
25.0%
1/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
2.9%
1/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
2.9%
1/34 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
|
0.00%
0/4 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 25 months.
A TEAE was any adverse event that emerged on or after the first dosing of double-blind study medication and during study treatment up to 4 weeks after the last dose of double-blind study medication (having been absent prior to treatment) or worsened relative to the pre-double-blind treatment state.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place