Trial Outcomes & Findings for Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU) (NCT NCT01212744)
NCT ID: NCT01212744
Last Updated: 2019-02-26
Results Overview
Plasma Phe
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
rAvPAL-PEG
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
rAvPAL-PEG
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)
Baseline characteristics by cohort
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
|
|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
|
Age, Customized
< 18 years of age
|
0 Participants
n=5 Participants
|
|
Age, Customized
> or = 18 years of age
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: The efficacy population will consist of all subjects who received any amount of study drug and have post-treatment blood Phe concentration measurements.
Plasma Phe
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Blood Phenylalanine Concentration
Baseline
|
1482.1 umol/L
Standard Deviation 363.46
|
|
Blood Phenylalanine Concentration
Week 16
|
1566.0 umol/L
Standard Deviation 586.11
|
SECONDARY outcome
Timeframe: WeeklyPopulation: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Safety will be evaluated on the incidence of AEs and clinically significant changes in vital signs as well as clinical labs and ECG. Please refer to AE section below for comprehensive listing of all adverse events recorded during study.
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Study Drug Related Adverse Events
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibody against phenylalanine ammonia lyase (PAL)
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With PAL IgG Antibody Percentage of Participants With Positive PAL IgG
Baseline
|
12.5 Percentage
|
|
Percentage of Participants With PAL IgG Antibody Percentage of Participants With Positive PAL IgG
Week 16
|
100.0 Percentage
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 13Population: The PK population will consist of all subjects who received any amount of study drug and have post-treatment plasma BMN 165 concentration measurements.
Measurements taken pre-dose
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Plasma Concentrations of rAvPAL-PEG (BMN 165)
Baseline-Day 1, 1 Hour Predose
|
0.000 ng/mL
Standard Deviation 0.0000
|
|
Plasma Concentrations of rAvPAL-PEG (BMN 165)
Week 8-Day 52, 1 Hour Predose
|
2425.608 ng/mL
Standard Deviation 8532.2431
|
|
Plasma Concentrations of rAvPAL-PEG (BMN 165)
Week 13-Day 89, Predose
|
1116.364 ng/mL
Standard Deviation 2013.9676
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibodies against polyethylene glycol (PEG) of the IgG isotype
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With PEG-IgG Antibody Positivity
Baseline
|
25.0 Percentage
|
|
Percentage of Participants With PEG-IgG Antibody Positivity
Week 16
|
75.0 Percentage
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibodies against phenylalanine ammonia lyase (PAL) of the IgM isotype
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With PAL-IgM Antibody Positivity
Baseline
|
12.5 Percentage
|
|
Percentage of Participants With PAL-IgM Antibody Positivity
Week 16
|
75.0 Percentage
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibodies against polyethylene glycol (PEG) of the IgM isotype
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With PEG-IgM Antibody Positivity
Baseline
|
31.3 Percentage
|
|
Percentage of Participants With PEG-IgM Antibody Positivity
Week 16
|
50.0 Percentage
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibody positivity over time
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With Neutralizing Antibody Positivity
Baseline
|
0.0 Percentage
|
|
Percentage of Participants With Neutralizing Antibody Positivity
Week 16
|
0.0 Percentage
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibodies against phenylalanine ammonia lyase (PAL) of the IgE isotype
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With PAL-IgE Antibody Positivity
Baseline
|
0.0 Percentage
|
|
Percentage of Participants With PAL-IgE Antibody Positivity
Week 16
|
0.0 Percentage
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).
Antibodies against phenylalanine ammonia lyase (PAL)-polyethylene glycol (PEG) of the IgE isotype
Outcome measures
| Measure |
rAvPAL-PEG
n=16 Participants
rAvPAL-PEG in varying doses
rAvPAL-PEG: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
|
|---|---|
|
Percentage of Participants With PAL-PEG-IgE Antibody Positivity
Baseline
|
0.0 Percentage
|
|
Percentage of Participants With PAL-PEG-IgE Antibody Positivity
Week 16
|
0.0 Percentage
|
Adverse Events
rAvPAL-PEG
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rAvPAL-PEG
n=16 participants at risk
rAvPAL-PEG in varying doses
|
|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
Other adverse events
| Measure |
rAvPAL-PEG
n=16 participants at risk
rAvPAL-PEG in varying doses
|
|---|---|
|
Eye disorders
Ocular hyperaemia
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
5/16 • Number of events 9 • Week 0- Week 16
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
4/16 • Number of events 5 • Week 0- Week 16
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Food poisoning
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 5 • Week 0- Week 16
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Chest discomfort
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
General disorders
Chills
|
18.8%
3/16 • Number of events 4 • Week 0- Week 16
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
General disorders
Hangover
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Infusion site erythema
|
12.5%
2/16 • Number of events 8 • Week 0- Week 16
|
|
General disorders
Injection site bruising
|
37.5%
6/16 • Number of events 11 • Week 0- Week 16
|
|
General disorders
Injection site erythema
|
50.0%
8/16 • Number of events 18 • Week 0- Week 16
|
|
General disorders
Injection site induration
|
6.2%
1/16 • Number of events 2 • Week 0- Week 16
|
|
General disorders
Injection site nodule
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Injection site oedema
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Injection site pain
|
43.8%
7/16 • Number of events 9 • Week 0- Week 16
|
|
General disorders
Injection site pruritus
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Injection site rash
|
25.0%
4/16 • Number of events 8 • Week 0- Week 16
|
|
General disorders
Injection site reaction
|
50.0%
8/16 • Number of events 32 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
25.0%
4/16 • Number of events 5 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
18.8%
3/16 • Number of events 4 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
18.8%
3/16 • Number of events 5 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
5/16 • Number of events 6 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
4/16 • Number of events 5 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Burning sensation
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Clonus
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Dizziness
|
56.2%
9/16 • Number of events 14 • Week 0- Week 16
|
|
Nervous system disorders
Dizziness postural
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Headache
|
62.5%
10/16 • Number of events 34 • Week 0- Week 16
|
|
Nervous system disorders
Hyperreflexia
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Nervous system disorders
Hypersomnia
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Lethargy
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Migraine
|
18.8%
3/16 • Number of events 5 • Week 0- Week 16
|
|
Nervous system disorders
Paraesthesia
|
12.5%
2/16 • Number of events 3 • Week 0- Week 16
|
|
Nervous system disorders
Sciatica
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Sinus headache
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Nervous system disorders
Tremor
|
25.0%
4/16 • Number of events 5 • Week 0- Week 16
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Psychiatric disorders
Nervousness
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Reproductive system and breast disorders
Uterine spasm
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 5 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
4/16 • Number of events 4 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.8%
3/16 • Number of events 4 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
12.5%
2/16 • Number of events 3 • Week 0- Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
2/16 • Number of events 5 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Number of events 9 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
37.5%
6/16 • Number of events 7 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.2%
1/16 • Number of events 2 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Surgical and medical procedures
Endodontic procedure
|
6.2%
1/16 • Number of events 2 • Week 0- Week 16
|
|
General disorders
Injection site swelling
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Injection site urticaria
|
25.0%
4/16 • Number of events 10 • Week 0- Week 16
|
|
General disorders
Injection site warmth
|
12.5%
2/16 • Number of events 3 • Week 0- Week 16
|
|
General disorders
Instillation site pruritus
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 6 • Week 0- Week 16
|
|
General disorders
Oedema peripheral
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 2 • Week 0- Week 16
|
|
General disorders
Pyrexia
|
31.2%
5/16 • Number of events 6 • Week 0- Week 16
|
|
General disorders
Swelling
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
General disorders
Vessel puncture site bruise
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Infections and infestations
Pharyngitis
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Infections and infestations
Tooth infection
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Investigations
C-reactive protein increased
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Investigations
Complement factor C3 decreased
|
18.8%
3/16 • Number of events 3 • Week 0- Week 16
|
|
Investigations
Complement factor C4 decreased
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Investigations
Complement factor decreased
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Investigations
Complement factor increased
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Investigations
Electrocardiogram ST segment depression
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Investigations
Weight decreased
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Number of events 2 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
75.0%
12/16 • Number of events 36 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
12.5%
2/16 • Number of events 3 • Week 0- Week 16
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
12.5%
2/16 • Number of events 3 • Week 0- Week 16
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 2 • Week 0- Week 16
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Ear and labyrinth disorders
Ear pruritus
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Ear and labyrinth disorders
Motion sickness
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
|
Vascular disorders
Orthostatic hypotension
|
6.2%
1/16 • Number of events 1 • Week 0- Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60