Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia (NCT NCT02718716)
NCT ID: NCT02718716
Last Updated: 2024-01-29
Results Overview
TEAEs were defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)
Results posted on
2024-01-29
Participant Flow
The study started to enroll patients in March 2016 and concluded in February 2019.
The study included a Screening Period (1 to 28 days), a Dosing Period of 1 to 4 weeks, and an Observation Period of 8 weeks. Participant Flow refers to the Safety Set.
Participant milestones
| Measure |
UCB7665 4 mg/kg
Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals.
|
UCB7665 7 mg/kg
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.
|
UCB7665 10 mg/kg
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.
|
UCB7665 15 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
|
UCB7665 20 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
14
|
15
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
UCB7665 4 mg/kg
Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals.
|
UCB7665 7 mg/kg
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.
|
UCB7665 10 mg/kg
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.
|
UCB7665 15 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
|
UCB7665 20 mg/kg
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
Baseline characteristics by cohort
| Measure |
UCB7665 4 mg/kg
n=15 Participants
Participants in this arm received 5 sc doses of UCB7665 (rozanolixizumab) 4 mg/kg at 1-week intervals.
|
UCB7665 7 mg/kg
n=15 Participants
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.
|
UCB7665 10 mg/kg
n=12 Participants
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.
|
UCB7665 15 mg/kg
n=12 Participants
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.
|
UCB7665 20 mg/kg
n=12 Participants
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.
|
Total Title
n=66 Participants
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 18.2 • n=21 Participants
|
50.8 years
STANDARD_DEVIATION 17.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)Population: The Safety Set (SS) consisted of all study participants who had received at least 1 infusion (full or partial infusion) of rozanolixizumab and was used for the analysis of safety data.
TEAEs were defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose.
Outcome measures
| Measure |
UCB7665 4 mg/kg (SS)
n=15 Participants
Participants in this arm received 5 sc doses of UCB7665 (rozanolixizumab) 4 mg/kg at 1-week intervals. Participants formed the Safety Set (SS).
|
UCB7665 7 mg/kg (SS)
n=15 Participants
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. Participants formed the SS.
|
UCB7665 10 mg/kg (SS)
n=12 Participants
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. Participants formed the SS.
|
UCB7665 15 mg/kg (SS)
n=12 Participants
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. Participants formed the SS.
|
UCB7665 20 mg/kg (SS)
n=12 Participants
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. Participants formed the SS.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study
|
80.0 percentage of participants
|
60.0 percentage of participants
|
58.3 percentage of participants
|
91.7 percentage of participants
|
100 percentage of participants
|
Adverse Events
UCB7665 4 mg/kg (SS)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
UCB7665 7 mg/kg (SS)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
UCB7665 10 mg/kg (SS)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
UCB7665 15 mg/kg (SS)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
UCB7665 20 mg/kg (SS)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UCB7665 4 mg/kg (SS)
n=15 participants at risk
Participants in this arm received 5 sc doses of UCB7665 (rozanolixizumab) 4 mg/kg at 1-week intervals. Participants formed the Safety Set (SS).
|
UCB7665 7 mg/kg (SS)
n=15 participants at risk
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. Participants formed the SS.
|
UCB7665 10 mg/kg (SS)
n=12 participants at risk
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. Participants formed the SS.
|
UCB7665 15 mg/kg (SS)
n=12 participants at risk
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. Participants formed the SS.
|
UCB7665 20 mg/kg (SS)
n=12 participants at risk
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. Participants formed the SS.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
Other adverse events
| Measure |
UCB7665 4 mg/kg (SS)
n=15 participants at risk
Participants in this arm received 5 sc doses of UCB7665 (rozanolixizumab) 4 mg/kg at 1-week intervals. Participants formed the Safety Set (SS).
|
UCB7665 7 mg/kg (SS)
n=15 participants at risk
Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals. Participants formed the SS.
|
UCB7665 10 mg/kg (SS)
n=12 participants at risk
Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals. Participants formed the SS.
|
UCB7665 15 mg/kg (SS)
n=12 participants at risk
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg. Participants formed the SS.
|
UCB7665 20 mg/kg (SS)
n=12 participants at risk
Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg. Participants formed the SS.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Eye disorders
Visual impairment
|
6.7%
1/15 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Eye disorders
Keratitis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
13.3%
2/15 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
33.3%
4/12 • Number of events 4 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
25.0%
3/12 • Number of events 3 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Asthenia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Chest discomfort
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Infusion site oedema
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Injection site reaction
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Viral infection
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
16.7%
2/12 • Number of events 4 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 3 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 6 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
40.0%
6/15 • Number of events 7 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
25.0%
3/12 • Number of events 4 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
41.7%
5/12 • Number of events 6 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
75.0%
9/12 • Number of events 9 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
6.7%
1/15 • Number of events 2 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/15 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
0.00%
0/12 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from Week 1 until the End-of-Study Visit (8 weeks following the final dose) (up to 12 weeks after the first dose of IMP)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60