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The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to <8 years of age will be enrolled.
Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB, a molecule that is activated from infancy in DMD and which is central to causing muscle damage and preventing muscle regeneration. Data on magnetic resonance imaging of the lower and upper leg muscles, physical function (including timed function tests) and muscle strength will be studied.
Part A was a 1-week, open-label study to assess safety, tolerability, pharmacokinetics and biomarkers for three dose levels of edasalonexent and is now complete.
Part B was a randomized, double-blind, placebo-controlled, multiple dose study to evaluate the safety, efficacy, PK, and PD of edasalonexent over 12 weeks. Patients who participated in Part A also participated in Part B, along with newly enrolled patients. Patients received either edasalonexent 67 mg/kg/day, edasalonexent 100 mg/kg/day, or placebo in Part B. Part B is now complete.
Following completion of Part B, patients receive edasalonexent for 138 weeks in Part C, the open-label portion of the MoveDMD study. Patients on the 67 mg/kg/day treatment moved to the 100 mg/kg/day treatment. Patients on the 100 mg/kg/day treatment remained on the 100 mg/kg/day treatment. If clinically indicated, concomitant treatment with eteplirsen (Exondys 51â„¢) may be acceptable in patients with amenable gene mutations during Part C after the patient has been exposed to edasalonexent for 6 months.
**Following completion of MoveDMD Part C, access to edasalonexent for trial participants will continue through the open-label extension study, GalaxyDMD.**
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day |
|
| Dose 2 | Experimental | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edasalonexent | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B | The LLC5-T2 calculated from the unweighted average of the T2 relaxation times of all 5 lower leg muscles for each patient at each evaluation (the medial gastrocnemius, peroneals, soleus, tibialis anterior, and tibialis posterior muscles). Increases in LLC5-T2 relaxation time indicate muscle damage, inflammation, edema, and fat infiltration and are highly correlated with muscle fat | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Speed of Completing the 10-meter Walk/Run Test (10MWT) at Week 12 - Part B and Part C | The 10MWT determines the speed to walk a distance of 10 meters. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed. |
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Inclusion Criteria:
Exclusion Criteria:
Use of corticosteroids within prior 6 months of treatment initiation or planning to initiate steroid therapy within the next 6 months
Other prior or ongoing significant medical conditions
Exposure to another investigational drug (such as eteplirsen or idebenone) within 28 days prior to start of study treatment or ongoing participation in any other therapeutic clinical trial
Patients who participated in Part A must meet the following criteria to participate in Part B:
There are no entry criteria for Part C; all patients who complete Part B will automatically continue in Part C
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90095 | United States | |||
A total of 32 patients were treated with edasalonexent in this study. 17 patients were enrolled in Part A and 16 completed 7 days of dosing, 1 patient screen failed due to inability to comply with study procedures and did not continue to Part B. A total of 31 patients (16 subjects from Part A and 15 New subjects who entered Part B) were enrolled in Part B, and all completed the 12 weeks of dosing. All 31 patients included in Part B enrolled in the open-label long-term extension phase, Part C.
This was a 3-part, Phase 1/2, multi-centre study conducted at 5 study centers in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Dose 1 | Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| FG001 | Part A: Dose 2 | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| FG002 | Part A: Dose 3 | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent |
| FG003 | Part B: Dose 1 | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| FG004 | Part B: Dose 2 | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent |
| FG005 | Part B: Placebo 1 | Placebo 67 mg/kg/day Capsules taken by mouth two times per day |
| FG006 | Part B: Placebo 2 | Placebo 100 mg/kg/day Capsules taken by mouth three times per day |
| FG007 | Part C: Dose 1 | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| FG008 | Part C: Dose 2 | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PartA(7 Day Open-Label Treatment Period) |
|
| ||||||||||||||||||
| Part B (12-week Double Blind) |
| |||||||||||||||||||
| Part C (138-week, Open-label Treatment) |
|
Safety population:
Part A:The Safety Population was all patients who received at least 1 dose of IP in Part A
Part B:The Safety Population was all patients who received at least 1 dose of IP in Part B.
Active B or C Safety Population: The Safety Population was all patients who received at least 1 dose of active treatment in Part B and all patients who received placebo in Part B and at least 1 dose of active treatment in Part C.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A -CAT-1004 33 mg/kg/Day | Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| BG001 | Part A - CAT-1004 67 mg/kg/Day | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Analysis population are reported separately based on Part A and Part B. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B | The LLC5-T2 calculated from the unweighted average of the T2 relaxation times of all 5 lower leg muscles for each patient at each evaluation (the medial gastrocnemius, peroneals, soleus, tibialis anterior, and tibialis posterior muscles). Increases in LLC5-T2 relaxation time indicate muscle damage, inflammation, edema, and fat infiltration and are highly correlated with muscle fat | Part B Full Analysis Population: The Full Analysis Population was a modified intent-to-treat population and consisted of all patients who received at least 1 dose of investigational product (IP) in Part B and had a valid baseline and at least 1 post baseline timed function test (TFT) or MRI efficacy assessment. | Posted | Mean | Standard Deviation | msec | Baseline to Week 12 |
|
Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A - CAT-1004 33 mg/kg/Day | Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Nichols, PhD - Chief Scientific Officer | Astria Therapeutics, Inc | 617-349-1971 | anichols@astriatx.com |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009136 | Muscular Dystrophies |
| D009140 | Musculoskeletal Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C000622102 | edasalonexent |
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| Placebo |
| Drug |
|
| Baseline to Week 12 |
| Change From Baseline in the Speed of Completing the 4-Stairs Climb Task at Week 12 - Part B and Part C | The 4-stair climb test determines the speed to climb 4 standard steps. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed. | Baseline to Week 12 |
| Change From Baseline in the Speed of Completing the Stand From Supine Task at Week 12 - Part B and Part C | The stand from supine test determines the speed to stand from a supine position. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed. | Baseline to Week 12 |
| Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | A TEAE was any adverse event (AE) that started during or after the first dose of IP through the end of the safety follow-up period. Part B TEAEs were those that started on or after the first dose date in Part B through the date of Week 12 clinic dose. TEAEs for the Part C (Active B or C) analysis were those that started on or after the first dose date of active treatment in Part B or Part C. Drug related AEs included those marked as "Related" or "Possibly Related" to the study treatment. | Screening to Week 152 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Orlando | Florida | 32827 | United States |
| Portland | Oregon | 97239 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Part A - CAT-1004 100 mg/kg/Day | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent |
| BG003 | Part B - CAT-1004 67 mg/kg/Day | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent |
| BG004 | Part B - CAT-1004 100 mg/kg/Day | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent |
| BG005 | Part B: Overall Placebo | Placebo1:Placebo 67 mg/kg/day Capsules taken by mouth two times per day Placebo2: Placebo 100 mg/kg/day Capsules taken by mouth three times per day |
| BG006 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Analysis population are reported separately based on Part A and Part B. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Analysis population are reported separately based on Part A and Part B. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Analysis population are reported separately based on Part A and Part B. | Count of Participants | Participants |
|
| Region of Enrollment | Analysis population are reported separately based on Part A and Part B | Count of Participants | Participants |
|
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
| OG001 | Part B - CAT-1004 100 mg/kg/Day | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent |
| OG002 | Part B - Placebo (Overall) | Placebo 67 mg/kg/day Capsules taken by mouth two times per day Placebo 100 mg/kg/day Capsules taken by mouth three times per day |
|
|
| Secondary | Change From Baseline in the Speed of Completing the 10-meter Walk/Run Test (10MWT) at Week 12 - Part B and Part C | The 10MWT determines the speed to walk a distance of 10 meters. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed. | The Active B or C Full Analysis Population consisted of the pooled patient populations of Parts B and C that received treatment in either part and had valid baseline and efficacy measurements. | Posted | Mean | Standard Deviation | 10 meters/sec | Baseline to Week 12 |
|
|
|
| Secondary | Change From Baseline in the Speed of Completing the 4-Stairs Climb Task at Week 12 - Part B and Part C | The 4-stair climb test determines the speed to climb 4 standard steps. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed. | The Active B or C Full Analysis Population consisted of the pooled patient populations of Parts B and C that received treatment in either part and had valid baseline and efficacy measurements. | Posted | Mean | Standard Deviation | 4 Stairs/Sec | Baseline to Week 12 |
|
|
|
| Secondary | Change From Baseline in the Speed of Completing the Stand From Supine Task at Week 12 - Part B and Part C | The stand from supine test determines the speed to stand from a supine position. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed. | Active B or C Full Analysis Population | Posted | Mean | Standard Deviation | /Sec | Baseline to Week 12 |
|
|
|
| Secondary | Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | A TEAE was any adverse event (AE) that started during or after the first dose of IP through the end of the safety follow-up period. Part B TEAEs were those that started on or after the first dose date in Part B through the date of Week 12 clinic dose. TEAEs for the Part C (Active B or C) analysis were those that started on or after the first dose date of active treatment in Part B or Part C. Drug related AEs included those marked as "Related" or "Possibly Related" to the study treatment. | Part A Safety Population (referred to in tables as All Dosed Patients) The Safety Population was all patients who received at least 1 dose of IP in Part A. Part B Safety Population: The Safety Population was all patients who received at least 1 dose of IP in Part B. Active B or C Safety Population: The Safety Population was all patients who received at least 1 dose of active treatment in Part B and all patients who received placebo in Part B and at least 1 dose of active treatment in Part C. | Posted | Count of Participants | Participants | Screening to Week 152 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Part A - CAT-1004 67 mg/kg/Day | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | Part A - CAT-1004 100 mg/kg/Day | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Part B - CAT-1004 67 mg/kg/Day | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent | 0 | 10 | 0 | 10 | 9 | 10 |
| EG004 | Part B - CAT-1004 100 mg/kg/Day | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent | 0 | 10 | 1 | 10 | 8 | 10 |
| EG005 | Part B - Overall Placebo | Placebo 67 mg/kg/day Capsules taken by mouth two times per day Placebo 100 mg/kg/day Capsules taken by mouth three times per day | 0 | 11 | 0 | 11 | 9 | 11 |
| EG006 | Part C - CAT-1004 67 mg/kg/Day | Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day Edasalonexent | 0 | 15 | 0 | 15 | 15 | 15 |
| EG007 | Part C - CAT-1004 100 mg/kg/Day | Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day Edasalonexent | 0 | 16 | 0 | 16 | 16 | 16 |
| Subcutaneous abscess | Infections and infestations | Systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Excessive eye blinking | Eye disorders | Systematic Assessment |
|
| Eyelid rash | Eye disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gait disturbance | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Ear infection | Infections and infestations | Systematic Assessment |
|
| Viral rash | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Coagulation time prolonged | Investigations | Systematic Assessment |
|
| Vitamin D decreased | Investigations | Systematic Assessment |
|
| Blood urine present | Investigations | Systematic Assessment |
|
| Body temperature increased | Investigations | Systematic Assessment |
|
| Cardiac murmur | Investigations | Systematic Assessment |
|
| Influenza B virus test positive | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Serum ferritin decreased | Investigations | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | Systematic Assessment |
|
| Weight gain poor | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendinous contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Weight bearing difficulty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | Systematic Assessment |
|
| Aggression | Psychiatric disorders | Systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | Systematic Assessment |
|
| Impulsive behaviour | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | Systematic Assessment |
|
| Stubbornness | Psychiatric disorders | Systematic Assessment |
|
| Negativism | Psychiatric disorders | Systematic Assessment |
|
| Sleep terror | Psychiatric disorders | Systematic Assessment |
|
| Tic | Psychiatric disorders | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | Systematic Assessment |
|
| Pectus excavatum | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | Systematic Assessment |
|
| Thirst | General disorders | Systematic Assessment |
|
| Abasia | General disorders | Systematic Assessment |
|
| Catheter site pain | General disorders | Systematic Assessment |
|
| Device occlusion | General disorders | Systematic Assessment |
|
| Peripheral swelling | General disorders | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | Systematic Assessment |
|
| Body tinea | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
|
| Impetigo | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Oral herpes | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Scarlet fever | Infections and infestations | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| Male |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Part B |
|
| Patients with any AE related to study drug |
|
| Patients with any SAE |
|
| Patients with any AE leading to discontinuation from study |
|
| Patients with any TEAE |
|
| Patients with any drug-related TEAE |
|
| Patients with any TEAE leading to study drug discontinuation |
|
| Patients with drug-related TEAEs leading to study drug discontinuation |
|