Trial Outcomes & Findings for Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism (NCT NCT04288115)
NCT ID: NCT04288115
Last Updated: 2023-11-18
Results Overview
Percent of eligible participants approached who consented to participate during the recruitment phase.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
The time from first consent signed to last consent signed. March 2021 to April 2022.
Results posted on
2023-11-18
Participant Flow
Participants were recruited based on opt-in/opt-out letter at 1 VA medical center between March 2021 and April 2022. The first participant was enrolled on March 24, 2021 and the last participant was enrolled in April 2022.
Of 52 enrolled participants, 50 were randomized to treatment.
Participant milestones
| Measure |
Levothyroxine Group ("Sham Discontinuation")
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
Levothyroxine: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
Placebo Group ("Real Discontinuation")
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Levothyroxine Group ("Sham Discontinuation")
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
Levothyroxine: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
Placebo Group ("Real Discontinuation")
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Pre-study SCH diagnosis could not be confirmed per study entry criteria
|
3
|
2
|
Baseline Characteristics
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
Baseline characteristics by cohort
| Measure |
Levothyroxine Group ("Sham Discontinuation")
n=21 Participants
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
Levothyroxine: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
Placebo Group ("Real Discontinuation")
n=24 Participants
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 7.9 • n=39 Participants
|
65.7 years
STANDARD_DEVIATION 10.6 • n=41 Participants
|
68.2 years
STANDARD_DEVIATION 9.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Weight
|
220.4 pounds
STANDARD_DEVIATION 58.4 • n=39 Participants
|
201.0 pounds
STANDARD_DEVIATION 61.5 • n=41 Participants
|
210.1 pounds
STANDARD_DEVIATION 60.2 • n=35 Participants
|
|
Body mass index
|
32.5 kg/m^2
STANDARD_DEVIATION 7.7 • n=39 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 7.8 • n=41 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 7.8 • n=35 Participants
|
|
Systolic Blood Pressure (SBP)
|
141.1 mm Hg
STANDARD_DEVIATION 19.7 • n=39 Participants
|
137.5 mm Hg
STANDARD_DEVIATION 16.8 • n=41 Participants
|
139.2 mm Hg
STANDARD_DEVIATION 18.1 • n=35 Participants
|
|
Diastolic Blood Pressure (DBP)
|
80.1 mm Hg
STANDARD_DEVIATION 8.7 • n=39 Participants
|
80.2 mm Hg
STANDARD_DEVIATION 11.7 • n=41 Participants
|
80.1 mm Hg
STANDARD_DEVIATION 10.3 • n=35 Participants
|
|
Pulse
|
68.3 beats/min
STANDARD_DEVIATION 15.7 • n=39 Participants
|
66.8 beats/min
STANDARD_DEVIATION 9.4 • n=41 Participants
|
67.5 beats/min
STANDARD_DEVIATION 12.6 • n=35 Participants
|
|
Total Cholesterol
|
148.1 mg/dL
STANDARD_DEVIATION 41.9 • n=39 Participants
|
179.8 mg/dL
STANDARD_DEVIATION 31.3 • n=41 Participants
|
165.0 mg/dL
STANDARD_DEVIATION 39.6 • n=35 Participants
|
|
LDL
|
77.5 mg/dL
STANDARD_DEVIATION 34.5 • n=39 Participants
|
104.2 mg/dL
STANDARD_DEVIATION 28.4 • n=41 Participants
|
91.7 mg/dL
STANDARD_DEVIATION 33.9 • n=35 Participants
|
|
HDL
|
42.4 mg/dL
STANDARD_DEVIATION 11.5 • n=39 Participants
|
53.3 mg/dL
STANDARD_DEVIATION 19.8 • n=41 Participants
|
48.2 mg/dL
STANDARD_DEVIATION 17.2 • n=35 Participants
|
|
Triglycerides
|
141.5 mg/dL
STANDARD_DEVIATION 68.0 • n=39 Participants
|
111.4 mg/dL
STANDARD_DEVIATION 48.0 • n=41 Participants
|
125.4 mg/dL
STANDARD_DEVIATION 59.5 • n=35 Participants
|
|
Levothyroxine (LT4) dose prior to enrollment, 25mcg
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
LT4 dose prior to enrollment, 50mcg
|
10 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
LT4 dose prior to enrollment, 75mcg
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
LT4 duration, < 2 yrs
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
LT4 duration, 2 to 7 yrs
|
10 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
LT4 duration, > 7 yrs
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
thyroid-stimulating hormone (TSH)
|
3.19 mIU/L
STANDARD_DEVIATION 1.42 • n=39 Participants
|
3.08 mIU/L
STANDARD_DEVIATION 0.99 • n=41 Participants
|
3.1 mIU/L
STANDARD_DEVIATION 1.2 • n=35 Participants
|
|
free thyroxine (FT4)
|
0.9 ng/dL
STANDARD_DEVIATION 0.1 • n=39 Participants
|
0.9 ng/dL
STANDARD_DEVIATION 0.1 • n=41 Participants
|
0.9 ng/dL
STANDARD_DEVIATION 0.1 • n=35 Participants
|
|
thyroid peroxidase (TPO) positivity
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Hypothyroid Symptoms score
|
21.1 scores on scale
STANDARD_DEVIATION 18.4 • n=39 Participants
|
27.1 scores on scale
STANDARD_DEVIATION 20.4 • n=41 Participants
|
24.3 scores on scale
STANDARD_DEVIATION 19.5 • n=35 Participants
|
|
Tiredness score
|
31.1 scores on scale
STANDARD_DEVIATION 23.9 • n=39 Participants
|
33.2 scores on scale
STANDARD_DEVIATION 23.7 • n=41 Participants
|
32.2 scores on scale
STANDARD_DEVIATION 23.5 • n=35 Participants
|
|
ThyPRO-39 score
|
20.5 scores on scale
STANDARD_DEVIATION 14.8 • n=39 Participants
|
18.4 scores on scale
STANDARD_DEVIATION 11.2 • n=41 Participants
|
19.4 scores on scale
STANDARD_DEVIATION 12.9 • n=35 Participants
|
|
EQ-5D Descriptive score
|
0.758 scores on scale
STANDARD_DEVIATION 0.193 • n=39 Participants
|
0.746 scores on scale
STANDARD_DEVIATION 0.229 • n=41 Participants
|
0.752 scores on scale
STANDARD_DEVIATION 0.210 • n=35 Participants
|
|
EQ-5D VAS score
|
72.0 scores on scale
STANDARD_DEVIATION 15.0 • n=39 Participants
|
77.3 scores on scale
STANDARD_DEVIATION 14.4 • n=41 Participants
|
74.8 scores on scale
STANDARD_DEVIATION 14.7 • n=35 Participants
|
PRIMARY outcome
Timeframe: The time from first consent signed to last consent signed. March 2021 to April 2022.Population: The number of patients consented divided by the total number of eligible patients contacted.
Percent of eligible participants approached who consented to participate during the recruitment phase.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=162 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Participants' Willingness to Enter the Trial
|
52 Participants
|
—
|
PRIMARY outcome
Timeframe: The time from first consent signed to last consent signed. March 2021 to April 2022. 13 months.Population: The number of participants enrolled divided by the length of recruitment period (13 months).
The number of enrolled (consented) participants divided by the length of the recruitment period.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=52 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Recruitment Rate
|
4 participants per month
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number of randomized participants that completed the trial divided by the total number of randomized participants.
Percentage of randomized participants who completed the trial.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=45 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Completion Rate
|
44 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: All randomized participants who completed 6 months follow-up visit. An intent-to-treat strategy was employed where participants were analyzed in the group to which they were randomized, regardless of protocol deviations.
The Hypothyroid Symptoms score from the Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire is assessed on a scale from 0 to 100, with higher scores indicating more symptoms.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=21 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
n=23 Participants
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score
Baseline
|
21.1 score on a scale
Standard Deviation 18.4
|
27.1 score on a scale
Standard Deviation 20.4
|
|
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score
6 weeks
|
22.0 score on a scale
Standard Deviation 17.7
|
25.3 score on a scale
Standard Deviation 21.9
|
|
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Hypothyroid Symptoms Score
6 months
|
22.9 score on a scale
Standard Deviation 19.5
|
28.3 score on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: All randomized participants who completed 6 months follow-up visit. An intent-to-treat strategy was employed where participants were analyzed in the group to which they were randomized, regardless of protocol deviations.
The Tiredness score from the Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire is assessed on a scale from 0 to 100, with higher scores indicating more tiredness.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=21 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
n=23 Participants
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score
Baseline
|
31.1 score on a scale
Standard Deviation 23.9
|
33.2 score on a scale
Standard Deviation 23.7
|
|
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score
6 weeks
|
33.0 score on a scale
Standard Deviation 23.6
|
31.1 score on a scale
Standard Deviation 24.3
|
|
Thyroid-specific Quality of Life Patient-Reported Outcome (ThyPRO) - Tiredness Score
6 months
|
32.8 score on a scale
Standard Deviation 22.1
|
27.6 score on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: 6 weeks and 6 monthsPopulation: All randomized participants who completed 6 months follow-up visit. An intent-to-treat strategy was employed where participants were analyzed into the group they were randomized, regardless of protocol deviations.
The EuroQoL \[EQ\] Group 5-Dimension Self-Report Questionnaire (EQ-5D) scores include the EQ-5D descriptive index, on a scale from -0.59 to 1.00. Higher scores indicate better quality of life. The EQ-5D scores include the score on the EQ visual-analogue scale (EQ-5D VAS), on a scale from 0 to 100. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=21 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
n=23 Participants
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
EQ-5D Descriptive Score 6 weeks
|
0.759 score on a scale
Standard Deviation 0.190
|
0.786 score on a scale
Standard Deviation 0.214
|
|
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
EQ-5D Descriptive Score 6 months
|
0.742 score on a scale
Standard Deviation 0.180
|
0.750 score on a scale
Standard Deviation 0.232
|
|
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
EQ-5D VAS 6 weeks
|
78.0 score on a scale
Standard Deviation 13.8
|
77.2 score on a scale
Standard Deviation 19.6
|
|
Euro Quality of Life 5-Dimension Self-Report Questionnaire (EQ-5D) Score at Week 6 and Month 6
EQ-5D VAS 6 months
|
68.4 score on a scale
Standard Deviation 21.2
|
79.9 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants who completed 6-8 weeks and 6 months follow-up visit.
Differences in mean 6-month lipid levels after adjusting for gender and baseline lipid level.
Outcome measures
| Measure |
Percentage of Eligible Patients Willing to Participate.
n=21 Participants
The percentage of eligible patients that were willing to participate and were enrolled (signed consent) from the total number of patients contacted.
|
Placebo Group ("Real Discontinuation")
n=23 Participants
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Lipid Levels
Total cholesterol 6 months
|
145.3 mg/dL
Standard Deviation 32.6
|
177.4 mg/dL
Standard Deviation 39.6
|
|
Lipid Levels
LDL 6 months
|
76.5 mg/dL
Standard Deviation 28.6
|
100.2 mg/dL
Standard Deviation 32.3
|
|
Lipid Levels
HDL 6 months
|
42.7 mg/dL
Standard Deviation 16.5
|
51.5 mg/dL
Standard Deviation 16.2
|
|
Lipid Levels
Triglycerides 6 months
|
137.5 mg/dL
Standard Deviation 66.8
|
139.7 mg/dL
Standard Deviation 68.4
|
Adverse Events
Levothyroxine Group ("Sham Discontinuation")
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Group ("Real Discontinuation")
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levothyroxine Group ("Sham Discontinuation")
n=21 participants at risk
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
Levothyroxine: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
Placebo Group ("Real Discontinuation")
n=23 participants at risk
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Gangrene of toe
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Cardiac disorders
catheter ablation of arrhythmogenic focus
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Surgical and medical procedures
revision posterior decompression cervical cord and fusion
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Surgical and medical procedures
transurethral prostatectomy
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic adenocarcinoma
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Surgical and medical procedures
fluoroscopy guided percutaneous insertion of drug eluting stent into coronary artery with contrast
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
Other adverse events
| Measure |
Levothyroxine Group ("Sham Discontinuation")
n=21 participants at risk
Continue the current dose of levothyroxine. The brand of levothyroxine to be used in this study will be Synthroid tablets of 25 mcg, 50 mcg, and 75 mcg (AbbVie Inc).
Levothyroxine: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
Placebo Group ("Real Discontinuation")
n=23 participants at risk
Stop the current dose of levothyroxine and take study placebo
Placebo: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
|
|---|---|---|
|
Surgical and medical procedures
dental restoration
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Nervous system disorders
dizziness
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
13.0%
3/23 • Number of events 3 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Eye disorders
dry eye
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
General disorders
fatigue
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
8.7%
2/23 • Number of events 3 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Cardiac disorders
fluttering heart
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
fracture of phalanx of foot
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Nervous system disorders
headache
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 2 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Surgical and medical procedures
hernia repair
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Vascular disorders
feels hot
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Vascular disorders
menopausal flushing
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Vascular disorders
hypertensive disorder
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Infections and infestations
bronchitis
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Musculoskeletal and connective tissue disorders
injection of knee
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
injury of lower leg
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Eye disorders
intravitreal injection of anti-vascular endothelial growth factor
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Renal and urinary disorders
kidney stone
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Respiratory, thoracic and mediastinal disorders
labored breathing
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Vascular disorders
low blood pressure
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
carcinoma of prostate
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Nervous system disorders
numbness of hand
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 2 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Infections and infestations
open wound of buttock
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Infections and infestations
open wound of hip region
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
injury of elbow
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
pain in coccyx
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Nervous system disorders
paresthesia of upper limb
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Skin and subcutaneous tissue disorders
removal of sebaceous cyst
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Cardiac disorders
restenosis
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Skin and subcutaneous tissue disorders
scalp itchy
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
shoulder pain
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Surgical and medical procedures
simple extraction of tooth
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Nervous system disorders
spasm
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
General disorders
lightheadedness
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Musculoskeletal and connective tissue disorders
multiple joint pain
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
fall on ice
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
fractured dental restoration
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Surgical and medical procedures
fixed prosthodontic procedure
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Gastrointestinal disorders
polyp of sigmoid colon
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Gastrointestinal disorders
polyp of transverse colon
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
fracture of rib
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Cardiac disorders
angina pectoris
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Gastrointestinal disorders
diarrhea
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
0.00%
0/23 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Injury, poisoning and procedural complications
fall
|
4.8%
1/21 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
8.7%
2/23 • Number of events 2 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Cardiac disorders
cardiac pacemaker replaced
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Infections and infestations
cellulitis
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Infections and infestations
COVID-19
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
8.7%
2/23 • Number of events 2 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Skin and subcutaneous tissue disorders
cut of foot
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Skin and subcutaneous tissue disorders
cut of hand
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/21 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
4.3%
1/23 • Number of events 1 • 6 months
Of the 50 randomized participants, 24 were assigned to the LT4 group and 26 were assigned to the placebo group. There were 5 post-randomization exclusions, resulting in 21 participants in the LT4 group and 24 participants in the placebo group. One participant in the placebo group was discontinued (participant choice) prior to Week 6. This resulted in 21 participants in the LT4 group and 23 participants in the placebo group for the final analysis cohort.
|
Additional Information
Spyridoula Maraka, MD, MS
Central Arkansas Veterans Healthcare System
Phone: (501) 257-5848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place