Trial Outcomes & Findings for The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran) (NCT NCT01961921)
NCT ID: NCT01961921
Last Updated: 2024-04-19
Results Overview
An AE is any untoward medical occurrence in a patient or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
From Baseline up to 56 days post last dose
Results posted on
2024-04-19
Participant Flow
A total of 27 subjects were enrolled.
Participant milestones
| Measure |
ALN-TTR02 (Patisiran)
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Baseline characteristics by cohort
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 15.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Familial Amyloidotic Polyneuropathy (FAP) Stage
FAP Stage I: Unimpaired ambulation
|
24 Participants
n=5 Participants
|
|
Familial Amyloidotic Polyneuropathy (FAP) Stage
FAP Stage II: Assistance with ambulation required
|
3 Participants
n=5 Participants
|
|
Familial Amyloidotic Polyneuropathy (FAP) Stage
FAP Stage III: Wheelchair-bound or bedridden
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 56 days post last dosePopulation: Safety Analysis Set: All participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a patient or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation
At least 1 Treatment Emergent Adverse Event (TAE)
|
26 participants
|
|
The Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation
At least 1 Serious Adverse Event (SAE)
|
7 participants
|
|
The Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation
Study Drug Discontinuation for any reason
|
2 participants
|
SECONDARY outcome
Timeframe: From Baseline up to 56 days post last dosePopulation: Full Analysis Set: All participants who were enrolled were included in the full analysis set.
TTR levels, measured using the enzyme-linked immunosorbent assay (ELISA) method.
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Percentage Change From Baseline in Serum TTR Levels
Individual TTR % change
|
-82.06 Percent Change
Standard Error 1.33
|
|
Percentage Change From Baseline in Serum TTR Levels
Individual Predose TTR % change
|
-79.73 Percent Change
Standard Error 1.45
|
|
Percentage Change From Baseline in Serum TTR Levels
Individual Max TTR % change
|
-92.54 Percent Change
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.
The mNIS+7 assessment is a composite measure of neurologic impairment that provides a comprehensive measure of large and small fiber function that encompasses the totality of the motor, sensory, and autonomic deficits seen in hereditary transthyretin-mediated amyloidosis (hATTR) patients with polyneuropathy. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome.
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Change From Baseline in the Modified Neuropathy Impairment Score +7 (mNIS+7)
Baseline
|
50.5 score on a scale
Interval 2.0 to 122.5
|
|
Change From Baseline in the Modified Neuropathy Impairment Score +7 (mNIS+7)
Change from Baseline at Month 24
|
-7.00 score on a scale
Interval -34.63 to 15.38
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.
The overall EQ-5D is measured on a scale from 0 to 1, with 0 being worst and 1 best. The EQ-VAS is measured on a scale of 0-100, with 0 being the worst and 100 the best. The R-ODS captures activity and social participation limitations in patients. The R-ODS score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)
EQ-5D Score at Baseline
|
0.76 Score on a scale
Interval 0.31 to 1.0
|
|
Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)
EQ-5D Score: Change from Baseline at Month 24
|
0.00 Score on a scale
Interval -0.22 to 0.17
|
|
Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)
EQ-VAS Score at Baseline
|
70.0 Score on a scale
Interval 30.0 to 98.0
|
|
Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)
EQ-VAS Score: Change from Baseline at Month 24
|
0.0 Score on a scale
Interval -25.0 to 30.0
|
|
Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)
R-ODS Score at Baseline
|
38.5 Score on a scale
Interval 15.0 to 48.0
|
|
Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)
R-ODS Score: Change from Baseline at Month 24
|
-1.0 Score on a scale
Interval -14.0 to 8.0
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.
The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10 meters.
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=22 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Change in Gait Speed With 10-meter Walk Test
Baseline
|
1.13 m/sec
Interval 0.4 to 2.2
|
|
Change in Gait Speed With 10-meter Walk Test
Change from Baseline at Month 24
|
0.09 m/sec
Interval -0.4 to 0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.
The mean (SEM) hand grip strength change from baseline at 24 months between patients who used patisiran with or without a concomitant TTR stabilizer.
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Mean Change From Baseline in Hand Grip Strength
Baseline
|
23.88 kg
Interval 3.2 to 49.3
|
|
Mean Change From Baseline in Hand Grip Strength
Change from Baseline at Month 24
|
1.54 kg
Interval -17.2 to 22.7
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.
Nutritional status of patients was evaluated using the mBMI, calculated as BMI (kg/m\^2) multiplied by albumin (g/L). An increase from baseline in mBMI suggests improvement, and a decrease from baseline suggests worsening.
Outcome measures
| Measure |
ALN-TTR02 (Patisiran)
n=27 Participants
Patients received 0.3 mg/kg of ALN-TTR02 (patisiran) every three weeks
|
|---|---|
|
Change From Baseline in Nutritional Status (Modified Body Mass Index, mBMI)
Baseline
|
1049.09 kg/m^2 x albumin g/L
Interval 728.6 to 1379.6
|
|
Change From Baseline in Nutritional Status (Modified Body Mass Index, mBMI)
Change from Baseline at Month 24
|
-39.85 kg/m^2 x albumin g/L
Interval -368.8 to 258.9
|
Adverse Events
Safety Population
Serious events: 7 serious events
Other events: 26 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Safety Population
n=27 participants at risk
All patients who received at least one dose of ALN-TTR02 (patisiran)
|
|---|---|
|
Cardiac disorders
Cardiac amyloidosis
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Myocardial infarction
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Abscess limb
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Osteomyelitis
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Ankle fracture
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Femur fracture
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Foot fracture
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Ligament rupture
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Thermal burn
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Tibia fracture
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Osteonecrosis
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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)
Oesophageal carcinoma
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Acute prerenal failure
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
|
Surgical and medical procedures
Arthrodesis
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Venous thrombosis limb
|
3.7%
1/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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 |
Safety Population
n=27 participants at risk
All patients who received at least one dose of ALN-TTR02 (patisiran)
|
|---|---|
|
Vascular disorders
Flushing
|
25.9%
7/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
22.2%
6/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Infusion related reaction
|
22.2%
6/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Nasopharyngitis
|
22.2%
6/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
22.2%
6/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Wound
|
22.2%
6/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
18.5%
5/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
18.5%
5/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
14.8%
4/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
14.8%
4/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
14.8%
4/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
|
Eye disorders
Cataract
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Infusion site extravasation
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
|
Eye disorders
Macular degeneration
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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 pain
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Osteoporosis
|
11.1%
3/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
|
Eye disorders
Macular fibrosis
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
|
Eye disorders
Visual acuity reduced
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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 pain
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Dyspepsia
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Early satiety
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Gait disturbance
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Infusion site erythema
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Pain
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Influenza
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Upper respiratory tract infection
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Wound infection
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Foot fracture
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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 thyroid stimulating hormone decreased
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Hypocalcaemia
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Osteoarthritis
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Osteopenia
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Hypoaesthesia
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Visual field defect
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Cough
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Erythema
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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
Skin ulcer
|
7.4%
2/27 • The investigators reported all AEs that occurred after the start of study drug administration on Day 0 (Baseline) through 21 or 56 days after the last dose of study drug administration (depending on enrollment into the open-label global extension study).
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