Trial Outcomes & Findings for Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares (NCT NCT00610363)
NCT ID: NCT00610363
Last Updated: 2017-05-02
Results Overview
A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.
COMPLETED
PHASE2
83 participants
Day 1 (Baseline) to Day 84 (Week 12)
2017-05-02
Participant Flow
The study was conducted at 27 study sites in United States (US) between 19 November 2007 and 16 October 2008. A total of 154 participants were screened in the study.
Out of 154 participants, 83 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Placebo or Rilonacept 160 mg.
Participant milestones
| Measure |
Placebo
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
|
Rilonacept 160 mg
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
31
|
38
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
|
Rilonacept 160 mg
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Overall Study
Non-compliance with protocol
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other than specified above
|
1
|
1
|
Baseline Characteristics
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 11.59 • n=99 Participants
|
51.9 years
STANDARD_DEVIATION 10.61 • n=107 Participants
|
51.0 years
STANDARD_DEVIATION 11.09 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
|
0.79 Number of gout flares per participant
Standard Deviation 1.071
|
0.15 Number of gout flares per participant
Standard Deviation 0.358
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
|
45.2 percentage of participants
|
14.6 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
|
0.30 number of gout flares
Standard Deviation 0.424
|
0.06 number of gout flares
Standard Deviation 0.178
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per participant was reported for this outcome measure.
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
|
5.17 Gout flare days
Standard Deviation 8.015
|
1.41 Gout flare days
Standard Deviation 5.230
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per month per participant was reported for this outcome measure.
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
|
2.09 Gout flare days
Standard Deviation 3.608
|
0.52 Gout flare days
Standard Deviation 1.779
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)
|
2.02 Gout flare days
Standard Deviation 4.51
|
0.22 Gout flare days
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 84 (Week 12)Population: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).
Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.
Outcome measures
| Measure |
Placebo
n=42 Participants
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 Participants
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)
|
0.87 Gout flare days
Standard Deviation 2.05
|
0.07 Gout flare days
Standard Deviation 0.26
|
Adverse Events
Placebo
Rilonacept 160 mg
Serious adverse events
| Measure |
Placebo
n=42 participants at risk
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 participants at risk
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
0.00%
0/41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Investigations
Blood creatinine increased
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
0.00%
0/41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Investigations
Blood urea increased
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
0.00%
0/41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Investigations
Creatinine renal clearance decreased
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
0.00%
0/41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Investigations
Protein urine present
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
0.00%
0/41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/42 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
2.4%
1/41 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
|
Rilonacept 160 mg
n=41 participants at risk
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
0.00%
0/41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Metabolism and nutrition disorders
Gout
|
7.1%
3/42 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
7.3%
3/41 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
2.4%
1/41 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/42 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
7.3%
3/41 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI/Institution will provide a copy of any publication to Sponsor prior to submission for review. Sponsor may request to remove confidential information from submission, provided that removal does not preclude the complete and accurate presentation and interpretation of the study results.
- Publication restrictions are in place
Restriction type: OTHER