Trial Outcomes & Findings for Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE) (NCT NCT00856206)
NCT ID: NCT00856206
Last Updated: 2017-04-28
Results Overview
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1315 participants
Primary outcome timeframe
Baseline up to Week 20
Results posted on
2017-04-28
Participant Flow
The study was conducted at 71 study sites in United States and rest of world (ROW) between 23 March 2009 and 14 January 2011. A total of 2311 participants were screened in the study.
Out of 2311 participants, 1315 were randomized and treated in the study. Participants were randomized in 3:1 ratio to receive Rilonacept 160 mg or placebo.
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 15.
|
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 15.
|
|---|---|---|
|
Overall Study
STARTED
|
330
|
985
|
|
Overall Study
COMPLETED
|
276
|
824
|
|
Overall Study
NOT COMPLETED
|
54
|
161
|
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 15.
|
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 15.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
18
|
|
Overall Study
Adverse Event
|
10
|
46
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
36
|
|
Overall Study
Lost to Follow-up
|
13
|
39
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Decision by the Sponsor
|
4
|
8
|
|
Overall Study
Other than specified above
|
3
|
10
|
Baseline Characteristics
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Baseline characteristics by cohort
| Measure |
Placebo
n=330 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 15.
|
Rilonacept 160 mg
n=985 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 15.
|
Total
n=1315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.55 • n=99 Participants
|
52.8 years
STANDARD_DEVIATION 11.48 • n=107 Participants
|
52.7 years
STANDARD_DEVIATION 11.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
297 Participants
n=99 Participants
|
857 Participants
n=107 Participants
|
1154 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
319 Participants
n=99 Participants
|
947 Participants
n=107 Participants
|
1266 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
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
47 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=99 Participants
|
202 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
210 Participants
n=99 Participants
|
658 Participants
n=107 Participants
|
868 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: Baseline up to Week 20Population: Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received.
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Outcome measures
| Measure |
Placebo
n=330 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 15.
|
Rilonacept 160 mg
n=985 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 15.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With at least 1 TEAE
|
59.1 percentage of participants
|
66.6 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With TEAEs related to study drug
|
13.0 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With serious TEAEs
|
3.9 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With TEAEs resulting in drug withdrawal
|
3.3 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With serious TEAEs resulting in drug withdrawal
|
1.8 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With TEAEs leading to study discontinuation
|
3.0 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
With serious TEAE leading to study discontinuation
|
1.5 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment emergent deaths
|
0.3 percentage of participants
|
0.2 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.
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 112 were counted, regardless whether the flares occurred during the treatment period or not.
Outcome measures
| Measure |
Placebo
n=323 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 15.
|
Rilonacept 160 mg
n=952 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 15.
|
|---|---|---|
|
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
|
1.73 Gout flares
Standard Deviation 2.69
|
0.51 Gout flares
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the 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. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.
Outcome measures
| Measure |
Placebo
n=330 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 15.
|
Rilonacept 160 mg
n=985 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 15.
|
|---|---|---|
|
Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)
|
51.1 percentage of participants
|
25.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the 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. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.
Outcome measures
| Measure |
Placebo
n=330 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 15.
|
Rilonacept 160 mg
n=985 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 15.
|
|---|---|---|
|
Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)
|
34.7 percentage of participants
|
11.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.
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. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.
Outcome measures
| Measure |
Placebo
n=323 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 15.
|
Rilonacept 160 mg
n=952 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 15.
|
|---|---|---|
|
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
|
7.66 Gout flare Days
Standard Deviation 11.79
|
2.66 Gout flare Days
Standard Deviation 7.69
|
Adverse Events
Placebo
Serious events: 13 serious events
Other events: 74 other events
Deaths: 0 deaths
Rilonacept 160 mg
Serious events: 31 serious events
Other events: 266 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=330 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 15.
|
Rilonacept 160 mg
n=985 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 15.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.20%
2/985 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.20%
2/985 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.20%
2/985 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.00%
0/985 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.00%
0/985 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
General disorders
Cyst
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.00%
0/985 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
General disorders
Death
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.00%
0/985 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
General disorders
Pyrexia
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Cellulitis
|
0.61%
2/330 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Meningitis viral
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.00%
0/985 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Sepsis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.00%
0/985 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Metabolism and nutrition disorders
Gout
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.20%
2/985 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.20%
2/985 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.20%
2/985 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Psychiatric disorders
Bipolar disorder
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Vascular disorders
Aneurysm
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/330 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Vascular disorders
Hypertension
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
0.10%
1/985 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
Other adverse events
| Measure |
Placebo
n=330 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 15.
|
Rilonacept 160 mg
n=985 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 15.
|
|---|---|---|
|
General disorders
Injection site erythema
|
0.30%
1/330 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
6.2%
61/985 • Number of events 195 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
6.1%
20/330 • Number of events 21 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
5.5%
54/985 • Number of events 61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
20/330 • Number of events 41 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
6.6%
65/985 • Number of events 85 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
15/330 • Number of events 21 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
5.3%
52/985 • Number of events 74 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
|
Nervous system disorders
Headache
|
7.9%
26/330 • Number of events 45 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
9.1%
90/985 • Number of events 169 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
|
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