Trial Outcomes & Findings for Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS) (NCT NCT03168711)
NCT ID: NCT03168711
Last Updated: 2021-02-18
Results Overview
Safety will be assessed by the occurrence of adverse events such as kidney stones and gout (expected adverse events) in all participants receiving at least 1 dose of study drug
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2021-02-18
Participant Flow
Participants age 18 and older who met the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS were recruited across three Northeast ALS Consortium (NEALS) Centers.
According to the study protocol all participants who consent to the study are considered enrolled. 23 consented participants were deemed ineligible during screening procedures and 2 withdrew consent. Of the 23 ineligible participants, 13 did not meet inclusion criteria and 10 were ineligible due to meeting exclusion criteria.
Participant milestones
| Measure |
Inosine
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
9
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Inosine
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)
Baseline characteristics by cohort
| Measure |
Inosine
n=14 Participants
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
n=9 Participants
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
56.4 years
STANDARD_DEVIATION 10 • n=107 Participants
|
58.6 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
9 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale Total Score
|
35.1 units on a scale
STANDARD_DEVIATION 8.4 • n=99 Participants
|
36.6 units on a scale
STANDARD_DEVIATION 6.8 • n=107 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale Bulbar Subdomain
|
8.6 units on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 3.2 • n=107 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale Fine-Motor Subdomain
|
8.5 units on a scale
STANDARD_DEVIATION 3.3 • n=99 Participants
|
8.4 units on a scale
STANDARD_DEVIATION 3.1 • n=107 Participants
|
8.5 units on a scale
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale Gross-Motor Subdomain
|
7.4 units on a scale
STANDARD_DEVIATION 2.7 • n=99 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale Respiratory Subdomain
|
10.5 units on a scale
STANDARD_DEVIATION 2.5 • n=99 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 0.88 • n=107 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 2.05 • n=206 Participants
|
|
Vital Capacity Percent Predicted Max
|
81.9 percentage predicted
STANDARD_DEVIATION 21.8 • n=99 Participants
|
86.1 percentage predicted
STANDARD_DEVIATION 29.5 • n=107 Participants
|
83.5 percentage predicted
STANDARD_DEVIATION 24.3 • n=206 Participants
|
|
Years from Symptom onset to Screening
|
1.97 years
STANDARD_DEVIATION 1.15 • n=99 Participants
|
2.56 years
STANDARD_DEVIATION 1.51 • n=107 Participants
|
2.2 years
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Years from Diagnosis to Screening
|
0.79 years
STANDARD_DEVIATION 0.73 • n=99 Participants
|
1.47 years
STANDARD_DEVIATION 1.33 • n=107 Participants
|
1.06 years
STANDARD_DEVIATION 1.04 • n=206 Participants
|
|
Years from Symptom onset to Diagnosis
|
1.18 years
STANDARD_DEVIATION 1.12 • n=99 Participants
|
1.08 years
STANDARD_DEVIATION 0.54 • n=107 Participants
|
1.14 years
STANDARD_DEVIATION 0.92 • n=206 Participants
|
|
Weight
|
72.7 kilograms
STANDARD_DEVIATION 10.3 • n=99 Participants
|
69.7 kilograms
STANDARD_DEVIATION 17.9 • n=107 Participants
|
71.5 kilograms
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
Urate
|
3.94 milligrams per deciliter
STANDARD_DEVIATION 1.11 • n=99 Participants
|
3.96 milligrams per deciliter
STANDARD_DEVIATION 0.48 • n=107 Participants
|
3.94 milligrams per deciliter
STANDARD_DEVIATION 0.90 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Safety will be assessed by the occurrence of adverse events such as kidney stones and gout (expected adverse events) in all participants receiving at least 1 dose of study drug
Outcome measures
| Measure |
Inosine
n=14 Participants
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
n=9 Participants
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
11 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Baseline to Week 20Tolerance of study drug will be defined as the number of participants who able to complete the 20-week study without permanently discontinuing study drug or suspending study drug for greater than 28 days
Outcome measures
| Measure |
Inosine
n=14 Participants
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
n=9 Participants
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
|---|---|---|
|
Tolerability to Complete the Entire 20 Week Study on Study Drug
|
12 Participants
|
7 Participants
|
Adverse Events
Inosine
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Inosine
n=14 participants at risk
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
n=9 participants at risk
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Infections and infestations
Device Related Infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
Other adverse events
| Measure |
Inosine
n=14 participants at risk
Subjects will be administered oral inosine daily. The dose of inosine will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Inosine: Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
|
Placebo
n=9 participants at risk
Subjects will be administered oral placebo daily. The dose of placebo will be titrated to obtain serum urate levels of 7 - 8 mg/dL.
Placebo: Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia Macrocytic
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Eye disorders
Eye Pruritus
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Eye disorders
Lacrimation Increased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
General disorders
Implant Site Pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Injury, poisoning and procedural complications
Eye Contusion
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Injury, poisoning and procedural complications
Fall
|
28.6%
4/14 • Number of events 6 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
14.3%
2/14 • Number of events 2 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Investigations
Blood Potassium Decreased
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Investigations
Electrocardiogram St Segment Elevation
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Investigations
Ph Urine Abnormal
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 2 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Investigations
Weight Decreased
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's Contracture
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 2 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Nervous system disorders
Muscle Contractions Involuntary
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Surgical and medical procedures
Central Venous Catheterisation
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Surgical and medical procedures
Medical Device Removal
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
0.00%
0/9 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of first participant consent through final participant's completion of the study. This covered an active study period of 2 years and 3 months. Participants were followed from time of consent through completion of their study participation or withdrawal of consent. Adverse event data was collected for 24 weeks.
Adverse Events classified by MedDRA system organ class, higher level term, and preferred term
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place