Trial Outcomes & Findings for Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes (NCT NCT01687595)
NCT ID: NCT01687595
Last Updated: 2021-07-13
Results Overview
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline, Weeks 6-13
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
HerpV + QS-21
Participants received a combination of HerpV (recombinant human heat shock protein 70 \[rh-Hsc70\] polyvalent peptide complex) 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
Participants received placebo (phosphate buffered saline \[PBS\]) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
10
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
70
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
70
|
10
|
Reasons for withdrawal
| Measure |
HerpV + QS-21
Participants received a combination of HerpV (recombinant human heat shock protein 70 \[rh-Hsc70\] polyvalent peptide complex) 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
Participants received placebo (phosphate buffered saline \[PBS\]) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Investigator's decision
|
1
|
0
|
|
Overall Study
Sponsor's decision
|
1
|
0
|
|
Overall Study
Noncompliance
|
1
|
2
|
|
Overall Study
Other than specified
|
56
|
7
|
Baseline Characteristics
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Baseline characteristics by cohort
| Measure |
HerpV + QS-21
n=70 Participants
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
n=10 Participants
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 6.22 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 6-13Population: Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for "HerpV + QS-21" arm only.
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
Outcome measures
| Measure |
HerpV + QS-21
n=70 Participants
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)
|
13.53 percentage change
Interval 2.38 to 23.4
|
—
|
PRIMARY outcome
Timeframe: Baseline, Weeks 26-33Population: Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for "HerpV + QS-21" arm only.
The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
Outcome measures
| Measure |
HerpV + QS-21
n=70 Participants
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)
|
12.78 percentage change
Interval 0.83 to 23.28
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 26Population: Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
HerpV + QS-21
n=61 Participants
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
n=8 Participants
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time
|
46 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 26Population: Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
HerpV + QS-21
n=61 Participants
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
n=8 Participants
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Number of Participants With CD8+ Immune Response at Any Time
|
32 Participants
|
2 Participants
|
Adverse Events
HerpV + QS-21
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HerpV + QS-21
n=70 participants at risk
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
n=10 participants at risk
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
Other adverse events
| Measure |
HerpV + QS-21
n=70 participants at risk
Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
Placebo
n=10 participants at risk
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
3/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Ear and labyrinth disorders
Hyperacusis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Endocrine disorders
Thyroid mass
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Eye disorders
Erythema of eyelid
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Eye disorders
Eye pruritus
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Eye disorders
Eyelid edema
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
4/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Diarrhea
|
35.7%
25/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
50.0%
5/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
30/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
60.0%
6/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Paresthesia, oral
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Tongue disorder
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Tooth impacted
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
5/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
20.0%
2/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Asthenia
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Axillary pain
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Chills
|
17.1%
12/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Fatigue
|
81.4%
57/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
60.0%
6/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Feeling cold
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Induration
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Inflammation
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Influenza-like illness
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site cyst
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site erythema
|
80.0%
56/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site hematoma
|
8.6%
6/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site induration
|
22.9%
16/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site pain
|
94.3%
66/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
50.0%
5/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site paresthesia
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site pruritus
|
25.7%
18/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site rash
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site swelling
|
60.0%
42/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site ulcer
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site vesicles
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Injection-site warmth
|
5.7%
4/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Pyrexia
|
15.7%
11/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
General disorders
Vaccination-site warmth
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Hepatobiliary disorders
Hypertransaminasemia
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Bronchitis
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Chlamydial infection
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Ear infection
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Folliculitis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Furuncle
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Gastroenteritis, viral
|
4.3%
3/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Influenza
|
5.7%
4/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
7/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Otitis media
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Perirectal abscess
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Pharyngitis, streptococcal
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Rash, pustular
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Sinusitis
|
7.1%
5/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Tooth infection
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
6/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Vaginal abscess
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
16.7%
1/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Infections and infestations
Vulvovaginitis
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Investigations
Blood glucose increased
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Investigations
Blood growth hormone decreased
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Investigations
Liver function test abnormal
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
80.0%
56/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
40.0%
4/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
3/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer, in situ
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer, stage II
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Balance disorder
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Dizziness
|
10.0%
7/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Headache
|
70.0%
49/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
70.0%
7/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Hyperesthesia
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Paresthesia
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Presyncope
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Nervous system disorders
Tremor
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Mid-cycle spotting
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Psychiatric disorders
Anxiety
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Psychiatric disorders
Depression
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Psychiatric disorders
Restlessness
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Psychiatric disorders
Sleep disorder
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Renal and urinary disorders
Bladder discomfort
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Renal and urinary disorders
Dysuria
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Renal and urinary disorders
Pyuria
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Breast mass
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Cervical polyp
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Penile pain
|
3.6%
1/28 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/4 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Reproductive system and breast disorders
Vaginal laceration
|
2.4%
1/42 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/6 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Dermatitis, contact
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Erythema, multiforme
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Pruritis, generalized
|
2.9%
2/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Rash, pruritic
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Vascular disorders
Flushing
|
0.00%
0/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
10.0%
1/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Vascular disorders
Hot flush
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
0.00%
0/10 • Baseline up to Week 76
Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place