Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip (NCT NCT01618708)
NCT ID: NCT01618708
Last Updated: 2016-07-11
Results Overview
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
357 participants
Primary outcome timeframe
From baseline to Week 26
Results posted on
2016-07-11
Participant Flow
The study was conducted at 42 centers in the US and Canada. A total of 1113 participants were screened between 05 September 2012 and 21 November 2014.
Of 1113 screened participants, 33 were re-screened, 357 were randomized and 741 were screen failures. Screen failures were mainly due to inclusion criteria not met and exclusion criteria met.
Participant milestones
| Measure |
Placebo
Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
182
|
|
Overall Study
Treated
|
172
|
180
|
|
Overall Study
COMPLETED
|
131
|
136
|
|
Overall Study
NOT COMPLETED
|
44
|
46
|
Reasons for withdrawal
| Measure |
Placebo
Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
10
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
17
|
22
|
|
Overall Study
Lack of Efficacy
|
8
|
8
|
|
Overall Study
Technical problems
|
2
|
0
|
|
Overall Study
Other than specified above
|
1
|
1
|
|
Overall Study
Randomized but not treated
|
3
|
2
|
Baseline Characteristics
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
Baseline characteristics by cohort
| Measure |
Placebo
n=175 Participants
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=182 Participants
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 26Population: ITT population.
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Outcome measures
| Measure |
Placebo
n=175 Participants
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=182 Participants
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
|
-2.26 units on a scale
Standard Error 0.17
|
-2.19 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: From Baseline to Week 26Population: ITT population.
WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Outcome measures
| Measure |
Placebo
n=175 Participants
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=182 Participants
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Change From Baseline in WOMAC A Score Over 26 Weeks
|
-2.26 units on a scale
Standard Error 0.16
|
-2.19 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: From baseline to Week 26Population: ITT population.
PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.
Outcome measures
| Measure |
Placebo
n=175 Participants
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=182 Participants
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
|
-2.06 units on a scale
Standard Error 0.17
|
-2.00 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: From Baseline to Week 26Population: ITT population.
WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.
Outcome measures
| Measure |
Placebo
n=175 Participants
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=182 Participants
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Percentage of WOMAC A1 Responder Over 26 Weeks
|
45.71 Percentage of participants
|
45.05 Percentage of participants
|
Adverse Events
Placebo
Serious events: 15 serious events
Other events: 33 other events
Deaths: 0 deaths
Synvisc-One
Serious events: 10 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=172 participants at risk
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=180 participants at risk
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Congenital, familial and genetic disorders
Intracranial lipoma
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
General disorders
Non-cardiac chest pain
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
4/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
4/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
1.1%
2/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.56%
1/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Psychiatric disorders
Confusional state
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Psychiatric disorders
Disorientation
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Surgical and medical procedures
Obesity surgery
|
0.58%
1/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
0.00%
0/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
Other adverse events
| Measure |
Placebo
n=172 participants at risk
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
|
Synvisc-One
n=180 participants at risk
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
20/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
17.8%
32/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
|
Nervous system disorders
Headache
|
8.1%
14/172 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
7.2%
13/180 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER