Trial Outcomes & Findings for The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant (NCT NCT02595983)
NCT ID: NCT02595983
Last Updated: 2019-03-28
Results Overview
A negative percentage change from baseline at Month 6 indicates a reduction in serum TTR level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Month 6
Results posted on
2019-03-28
Participant Flow
A total of 12 participants with hereditary Transthyretin-mediated Amyloidosis (ATTR) with polyneuropathy who had neuropathy progression following post-orthotopic liver transplant (OLT) were enrolled and treated in this study.
Participant milestones
| Measure |
All Patients
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant
Baseline characteristics by cohort
| Measure |
All Patients
n=12 Participants
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Familial Amyloidotic Polyneuropathy (FAP) Stage
FAP Stage I: Unimpaired ambulation
|
3 Participants
n=5 Participants
|
|
Familial Amyloidotic Polyneuropathy (FAP) Stage
FAP Stage II: Assistance with ambulation required
|
9 Participants
n=5 Participants
|
|
Familial Amyloidotic Polyneuropathy (FAP) Stage
FAP Stage III: Wheelchair-bound or bedridden
|
0 Participants
n=5 Participants
|
|
Serum Transthyretin (TTR)
|
192.3 micrograms/milliliter (μg/mL)
STANDARD_DEVIATION 43.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at Month 6.
A negative percentage change from baseline at Month 6 indicates a reduction in serum TTR level.
Outcome measures
| Measure |
All Patients
n=7 Participants
All patients who received at least 1 dose of study drug
|
|---|---|
|
Percentage Change From Baseline in Serum TTR at Month 6
|
-72.0 percentage change from baseline in TTR
Standard Deviation 18.39
|
SECONDARY outcome
Timeframe: Weeks 3, 7, 12, 18, 24, 26 (Month 6), 39 (Month 9), 52 (Month 12), 57, 78 (Month 18)Population: Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.
A negative percentage change from baseline indicates a reduction in serum TTR level.
Outcome measures
| Measure |
All Patients
n=12 Participants
All patients who received at least 1 dose of study drug
|
|---|---|
|
Percentage Change From Baseline in Serum TTR Over 18 Months
Week 3
|
-75.1 percentage change from baseline in TTR
Standard Deviation 18.79
|
|
Percentage Change From Baseline in Serum TTR Over 18 Months
Week 7
|
-79.0 percentage change from baseline in TTR
Standard Deviation 15.46
|
|
Percentage Change From Baseline in Serum TTR Over 18 Months
Week 12
|
-73.0 percentage change from baseline in TTR
Standard Deviation 18.61
|
|
Percentage Change From Baseline in Serum TTR Over 18 Months
Week 18
|
-73.5 percentage change from baseline in TTR
Standard Deviation 14.30
|
|
Percentage Change From Baseline in Serum TTR Over 18 Months
Week 24
|
-73.4 percentage change from baseline in TTR
Standard Deviation 14.32
|
|
Percentage Change From Baseline in Serum TTR Over 18 Months
Week 26 (Month 6)
|
-72.0 percentage change from baseline in TTR
Standard Deviation 18.39
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 18Population: Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.
The mNIS+7 is a composite score that measures neurologic impairment which includes the following components: physical exam of lower limbs, upper limbs and cranial nerves to assess motor strength/weakness, electrophysiologic measurement of small and large nerve fiber function, sensory testing and postural blood pressure. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
All Patients
n=12 Participants
All patients who received at least 1 dose of study drug
|
|---|---|
|
Change From Baseline in Modified Neurological Impairment Score (mNIS +7) Composite Score Over 18 Months
Baseline
|
90.4 score on a scale
Standard Deviation 43.76
|
|
Change From Baseline in Modified Neurological Impairment Score (mNIS +7) Composite Score Over 18 Months
Change from baseline at Month 6
|
6.9 score on a scale
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 18Population: Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.
The Norfolk QoL-DN questionnaire is a standardized 35-item patient-reported outcomes measure that is sensitive to the different features of diabetic neuropathy - small fiber, large fiber, and autonomic nerve function. The minimum and maximum values are -4 and 136, respectively. A higher score indicates a worse outcome.
Outcome measures
| Measure |
All Patients
n=12 Participants
All patients who received at least 1 dose of study drug
|
|---|---|
|
Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Score
Baseline
|
61.3 score on a scale
Standard Deviation 24.86
|
|
Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Score
Month 6
|
77.1 score on a scale
Standard Deviation 31.06
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 18Population: Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected post-baseline. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.
PND Scores: Stage 0: No symptoms, Stage 1: Sensory disturbances but preserved walking capabilities, Stage 2: Impaired walking capacity, but ability to walk without a stick or crutches, Stage 3A/B: Walking with help of 1 or 2 sticks or crutches, Stage 4: confined to wheel chair. For each stage (0-4) at baseline, the number of participants is presented at their worst post-baseline score for each stage (0-4) post-baseline. Worst post-baseline is defined the highest PND classification for a participant recorded after the first dose of study drug.
Outcome measures
| Measure |
All Patients
n=11 Participants
All patients who received at least 1 dose of study drug
|
|---|---|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 0, Post-baseline Stage 0
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 0, Post-baseline Stage 1
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 0, Post-baseline Stage 2
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 0, Post-baseline Stage 3A/B
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 0, Post-baseline Stage 4
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 1, Post-baseline Stage 0
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 1, Post-baseline Stage 1
|
1 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 1, Post-baseline Stage 2
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 1, Post-baseline Stage 3A/B
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 1, Post-baseline Stage 4
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 2, Post-baseline Stage 0
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 2, Post-baseline Stage 1
|
1 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 2, Post-baseline Stage 2
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 2, Post-baseline Stage 3A/B
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 2, Post-baseline Stage 4
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 3A/B, Post-baseline Stage 0
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 3A/B, Post-baseline Stage 1
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 3A/B, Post-baseline Stage 2
|
1 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 3A/B, Post-baseline Stage 3A/B
|
6 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 3A/B, Post-baseline Stage 4
|
2 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 4, Post-baseline Stage 0
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 4, Post-baseline Stage 1
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 4, Post-baseline Stage 2
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 4, Post-baseline Stage 3A/B
|
0 Participants
|
|
Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
Baseline Stage 4, Post-baseline Stage 4
|
0 Participants
|
Adverse Events
Safety Population
Serious events: 8 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Safety Population
n=12 participants at risk
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Cardiac disorders
Cardiac Failure
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Ascites
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Death
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Aspergillus infection
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Pyelonephritis acute
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Septic Shock
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Urinary tract infections
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Blood immunoglobulin M increased
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenma
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Coma
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Hypercapnic Coma
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Loss of consciousness
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Psychiatric disorders
Confusional State
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Renal and urinary disorders
Renal Failure
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
Other adverse events
| Measure |
Safety Population
n=12 participants at risk
All patients who received at least 1 dose of revusiran
|
|---|---|
|
General disorders
Oedema peripheral
|
33.3%
4/12 • Number of events 6 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
25.0%
3/12 • Number of events 3 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • Number of events 4 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 5 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Renal and urinary disorders
Renal Failure
|
25.0%
3/12 • Number of events 4 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Number of events 4 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12 • Number of events 4 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Blood and lymphatic system disorders
Marcocytosis
|
25.0%
3/12 • Number of events 3 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 4 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • Number of events 4 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Cardiac disorders
Cardiac Failure
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Injection Site Erythema
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 2 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Injection site haematomia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Endocrine disorders
Adrenal insufficiency
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Hepatic enzyme increased
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Generalized Oedema
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Injection site bruising
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Speech disorder
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Eye disorders
Retinal vein occlusion
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Aphasia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Secretion discharge
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Neuralgia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Neuropathy peripheral
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Cardiac disorders
Cardiomyopathy
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Prothrombin level decreased
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Blood lactic acid increased
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Blood pyruvic acid increased
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Injury, poisoning and procedural complications
Eschar
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Somnolence
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Gastrointestinal disorders
Aerophagia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Blood pressure abnormal
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Investigations
Liver function test abnormal
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Nervous system disorders
Polyneuropathy
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
8.3%
1/12 • Number of events 1 • All adverse events (AEs) that occurred after the start of study drug administration on Day 0 (Baseline) up to 90 days post modified early termination visit (End of Study)
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60