Trial Outcomes & Findings for A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis (NCT NCT02292186)
NCT ID: NCT02292186
Last Updated: 2020-07-09
Results Overview
The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study \[drug\] discontinuation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months
Results posted on
2020-07-09
Participant Flow
Participant milestones
| Measure |
Revusiran (ALN-TTRSC)
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Baseline characteristics by cohort
| Measure |
Revusiran (ALN-TTRSC)
n=25 Participants
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 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
|
PRIMARY outcome
Timeframe: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 monthsThe proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study \[drug\] discontinuation.
Outcome measures
| Measure |
Revusiran (ALN-TTRSC)
n=25 Participants
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.
At least 1 AE (adverse event)
|
25 Participants
|
|
Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.
At least 1 SAE (serious adverse event)
|
22 Participants
|
|
Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.
Study discontinuation for any reason
|
18 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 monthsPopulation: Long term samples not collected due to study termination; no data to analyze
Pharmacodynamic (PD) effect of long-term dosing of ALN-TTRSC on serum levels of TTR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 monthsTotal number of deaths in the study and total number of deaths adjudicated as being related to cardiovascular causes. Deaths were adjudicated by an independent adjudication committee as cardiovascular (CV) or non-CV events.
Outcome measures
| Measure |
Revusiran (ALN-TTRSC)
n=25 Participants
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Mortality
Total deaths
|
8 Participants
|
|
Mortality
Total CV mortality events
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 monthsHospitalization events were adjudicated by an independent committee as cardiovascular (CV) or non-CV events
Outcome measures
| Measure |
Revusiran (ALN-TTRSC)
n=25 Participants
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization
At least 1 hospitalization event on study
|
17 Participants
|
|
Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization
At least 1 CV hospitalization event
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6, and Month 12Population: Number of participants analyzed differs from baseline to 6 and 12 months due to study discontinuations
Distance in meters walked in 6 minutes
Outcome measures
| Measure |
Revusiran (ALN-TTRSC)
n=25 Participants
All patients who received at least 1 dose of revusiran
|
|---|---|
|
6-minute Walk Test Performance
Change from baseline at Month 6
|
-20.6 meters
Standard Deviation 46.1
|
|
6-minute Walk Test Performance
Change from baseline at Month 12
|
-104.6 meters
Standard Deviation 88.6
|
Adverse Events
Revusiran (ALN-TTRSC)
Serious events: 22 serious events
Other events: 25 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Revusiran (ALN-TTRSC)
n=25 participants at risk
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Nervous system disorders
Neuropathy peripheral
|
28.0%
7/25 • Number of events 8 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Cardiac failure
|
24.0%
6/25 • Number of events 6 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Vascular disorders
Hypotension
|
24.0%
6/25 • Number of events 6 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Blood lactic acid increased
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Cardiac failure congestive
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Pneumonia
|
12.0%
3/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Renal and urinary disorders
Renal impairment
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Atrial fibrillation
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Cardiac arrest
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Cardiac failure acute
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Cardiogenic shock
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Cerebrovascular accident
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Fluid overload
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Lower respiratory tract infection
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Neuralgia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Renal and urinary disorders
Renal failure acute
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Sepsis
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Generalised oedema
|
4.0%
1/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Immune system disorders
Amyloidosis
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Renal and urinary disorders
Obstructive uropathy
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Left ventricular dysfunction
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Atrial flutter
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Depressed level of consciousness
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Psychiatric disorders
Completed suicide
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Right ventricular failure
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Renal and urinary disorders
Renal failure chronic
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Asthenia
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.0%
1/25 • Number of events 1 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
Other adverse events
| Measure |
Revusiran (ALN-TTRSC)
n=25 participants at risk
All patients who received at least 1 dose of revusiran
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
48.0%
12/25 • Number of events 17 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Dizziness
|
40.0%
10/25 • Number of events 14 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Neuropathy peripheral
|
36.0%
9/25 • Number of events 12 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Fall
|
40.0%
10/25 • Number of events 11 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Vascular disorders
Hypotension
|
16.0%
4/25 • Number of events 5 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Constipation
|
36.0%
9/25 • Number of events 10 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.0%
7/25 • Number of events 10 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Oedema peripheral
|
36.0%
9/25 • Number of events 13 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Fatigue
|
32.0%
8/25 • Number of events 8 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site erythema
|
32.0%
8/25 • Number of events 41 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Atrial fibrillation
|
28.0%
7/25 • Number of events 7 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Urinary tract infection
|
28.0%
7/25 • Number of events 8 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Weight decreased
|
28.0%
7/25 • Number of events 9 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Diarrhoea
|
24.0%
6/25 • Number of events 6 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site pruritus
|
24.0%
6/25 • Number of events 29 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
24.0%
6/25 • Number of events 7 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Blood lactic acid increased
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
4/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Fluid overload
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site pain
|
20.0%
5/25 • Number of events 14 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
International normalized ratio increased
|
20.0%
5/25 • Number of events 8 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 5 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
5/25 • Number of events 7 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Renal and urinary disorders
Renal failure acute
|
16.0%
4/25 • Number of events 5 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Lower respiratory tract infection
|
12.0%
3/25 • Number of events 5 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Contusion
|
16.0%
4/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site swelling
|
16.0%
4/25 • Number of events 16 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Liver function test abnormal
|
16.0%
4/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Vascular disorders
Orthostatic hypotension
|
16.0%
4/25 • Number of events 6 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Vitamin A decreased
|
16.0%
4/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Cardiac failure
|
16.0%
4/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Blood creatinine increased
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Investigations
Blood urea increased
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Renal and urinary disorders
Urinary retention
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Excoriation
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Tooth infection
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Vascular disorders
Flushing
|
8.0%
2/25 • Number of events 8 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • Number of events 4 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Laceration
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site discoloration
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Bronchitis
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Cardiac disorders
Pericardial effusion
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Psychiatric disorders
Depression
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Pyrexia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site inflammation
|
8.0%
2/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Metabolism and nutrition disorders
Gout
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Infections and infestations
Onychomycosis
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Tremor
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Nervous system disorders
Dysgeusia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Ear and labyrinth disorders
Vertigo
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disk degeneration
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
|
General disorders
Injection site haematoma
|
8.0%
2/25 • Number of events 2 • All 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); Mean duration of collection was 16 months.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60