Trial Outcomes & Findings for Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors (NCT NCT03094416)

NCT ID: NCT03094416

Last Updated: 2022-04-05

Results Overview

Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 66 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2022-04-05

Participant Flow

Subject were recuited by endocrinologists, either at hospital sites or at private practices

Enrolled subjects underwent a run-in period of 28-42 days, that may be extended up to 4 months, until Thyroid Stimulating Hormone (TSH) normalization, if levothyroxine sodium (LT4) dose adjustments were necessary at screening visit.

Participant milestones

Measure	Tirosint Capsules During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.
Run-in STARTED	66
Run-in COMPLETED	47
Run-in NOT COMPLETED	19
Treatment Period STARTED	47
Treatment Period COMPLETED	45
Treatment Period NOT COMPLETED	2

Reasons for withdrawal

Measure	Tirosint Capsules During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.
Run-in Screening failure	8
Run-in Sponsor Decision To Discontinue Due To Global Covid-19 Pandemic	8
Run-in Withdrawal by Subject	3
Treatment Period Withdrawal by Subject	2

Baseline Characteristics

Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Baseline characteristics by cohort

Measure	Tirosint Capsules n=47 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.
Age, Continuous	55.38 years STANDARD_DEVIATION 11.111 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Peru	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Puerto Rican	1 Participants n=5 Participants
Race/Ethnicity, Customized Ecuadorian	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Region of Enrollment United States	47 Participants n=5 Participants
Thyroid Stimulating Hormone (TSH)	1.341 mIU/L STANDARD_DEVIATION 1.5054 • n=5 Participants
Body Mass Index (BMI)	32.25 kg/m^2 STANDARD_DEVIATION 8.286 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: intention to treat (ITT), 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Thyroid Stimulating Hormone (TSH)

-0.676 mIU/L Standard Deviation 1.3181

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of FT4 (free thyroxine) from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Free Thyroxine (FT4)

0.593 pmol/L Standard Deviation 2.7439

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of TT4 (total thyroxine) from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Total Thyroxine (TT4)

2.558 nmol/L Standard Deviation 27.2426

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of FT3 (free triiodothyronine) from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Free Triiodothyronine (FT3)

0.263 pmol/L Standard Deviation 0.5716

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of TT3 (total triiodothyronine) from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Total Triiodothyronine (TT3)

0.098 nmol/L Standard Deviation 0.3158

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 6 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in Serum Levels of creatine phosphokinase (CPK) from Baseline

Outcome measures

Measure

Tirosint Capsules n=41 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Creatine Phosphokinase (CPK)

-35.073 U/L Standard Deviation 125.1454

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of SHBG (sex hormone binding globuline) from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Sex Hormone Binding Globulin (SHBG)

0.884 nmol/L Standard Deviation 19.1861

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 4 subjects not considered in the analysis because of drop-out or LT4 dose change

Change in Serum Levels of ferritin from Baseline

Outcome measures

Measure

Tirosint Capsules n=43 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Ferritin

-6.442 mcg/L Standard Deviation 30.2390

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 9 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in Serum Levels of ACE (angiotensin converting enzyme) from Baseline

Outcome measures

Measure

Tirosint Capsules n=38 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Angiotensin Converting Enzyme (ACE)

-0.395 U/L Standard Deviation 11.6237

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in triglycerides levels from Baseline

Outcome measures

Measure

Tirosint Capsules n=40 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Triglycerides

0.075 mmol/L Standard Deviation 0.5419

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in total cholesterol levels from Baseline

Outcome measures

Measure

Tirosint Capsules n=40 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Cholesterol, Total

-0.198 mmol/L Standard Deviation 0.6685

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 8 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in low density lipoprotein (LDL)-cholesterol levels from baseline

Outcome measures

Measure

Tirosint Capsules n=39 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Low Density Lipoprotein (LDL)-Cholesterol

-0.210 mmol/L Standard Deviation 0.5609

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 7 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in High Density Lipoprotein (HDL)-cholesterol levels from baseline

Outcome measures

Measure

Tirosint Capsules n=40 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

High Density Lipoprotein (HDL)-Cholesterol

-0.029 mmol/L Standard Deviation 0.2460

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks

Population: ITT, 8 subjects not considered in the analysis because of drop-out, LT4 dose change or laboratory test not performed

Change in Very Low Density Lipoprotein (VLDL)-cholesterol levels from baseline

Outcome measures

Measure

Tirosint Capsules n=39 Participants During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.

Very Low Density Lipoprotein (VLDL)-Cholesterol

0.049 mmol/L Standard Deviation 0.2338

Adverse Events

Treatment Period: Tirosint Capsules

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Run-in Period: LT4 Tablets

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Period: Tirosint Capsules n=47 participants at risk After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.	Run-in Period: LT4 Tablets n=47 participants at risk During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.
Respiratory, thoracic and mediastinal disorders Asthma	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Cardiac disorders Bradycardia	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Bronchitis	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Urinary tract infection	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Metabolism and nutrition disorders Dehydration	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks

Other adverse events

Measure	Treatment Period: Tirosint Capsules n=47 participants at risk After the run-in period, at baseline visit, subjects were switched to Tirosint (levothyroxine sodium) capsules at the same dose used during run-in and for 3 months (treatment period). For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.	Run-in Period: LT4 Tablets n=47 participants at risk During the run-in period, subjects continued taking their levothyroxine sodium tablet medication 88 to 250 mcg/day (depending on individual needs) as per prescription and as before inclusion. For the whole study duration (run-in and treatment period), subjects kept taking their proton pump inhibitor medication, as per prescription and as before inclusion.
Gastrointestinal disorders Diarrhoea	4.3% 2/47 • Number of events 2 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Upper respiratory tract infection	4.3% 2/47 • Number of events 2 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Gastrointestinal disorders Nausea	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Gastrointestinal disorders Vomiting	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
General disorders Fatigue	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	4.3% 2/47 • Number of events 2 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Bronchitis	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	4.3% 2/47 • Number of events 2 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Urinary tract infection	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Nervous system disorders Headache	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	4.3% 2/47 • Number of events 2 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Gastrointestinal disorders Constipation	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Gastrointestinal disorders Abdominal pain upper	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Pharyngitis	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Gastroenteritis	2.1% 1/47 • Number of events 2 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Infections and infestations Subcutaneous abscess	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Metabolism and nutrition disorders Hyperlipidaemia	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Injury, poisoning and procedural complications Joint injury	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Injury, poisoning and procedural complications Muscle strain	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Nervous system disorders Dizziness	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks
Respiratory, thoracic and mediastinal disorders Cough	2.1% 1/47 • Number of events 1 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks	0.00% 0/47 • Adverse events were collected for the whole study duration (from the signature of the informed consent until the end of the study and/or the follow-up planned period), an average of 18 weeks

Additional Information

Claudia Scarsi

IBSA

Phone: +41583601000

Email: claudia.scarsi@ibsa.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60