Trial Outcomes & Findings for 12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis. (NCT NCT00735007)

Last Updated: 2013-11-14

Results Overview

RebiSmart was evaluated as "very suitable or suitable"; "a little suitable"; or "not suitable at all" for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

End of 12 week treatment period

Results posted on

2013-11-14

Participant Flow

First Patient First Visit : 30 July 2008 Last Patient Last Visit: 27 January 2009 15 specialist neurology centres in 6 countries: Canada (3 sites), Germany(4 sites) , Italy (2 sites) , Spain(3 sites), Sweden (1 sites), USA(2 sites)

Participant milestones

Participant milestones
Measure	RebiSmart for Self-injection Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Study STARTED	106
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	RebiSmart for Self-injection Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Study Adverse Event	4
Overall Study Protocol Violation	1

Baseline Characteristics

12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	41.7 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Region of Enrollment Canada	16 participants n=5 Participants
Region of Enrollment Spain	24 participants n=5 Participants
Region of Enrollment Germany	26 participants n=5 Participants
Region of Enrollment Italy	14 participants n=5 Participants
Region of Enrollment Sweden	5 participants n=5 Participants
Diastolic blood pressure	75.5 mmHg STANDARD_DEVIATION 10.1 • n=5 Participants
Heart rate	74.9 beats/min STANDARD_DEVIATION 9.0 • n=5 Participants
Temperature	36.40 °C STANDARD_DEVIATION 0.43 • n=5 Participants
Thyroid Peroxidase antibody	220 IU/ml STANDARD_DEVIATION 181.9 • n=5 Participants
Systolic Blood Pressure	118.4 mmHg STANDARD_DEVIATION 13.1 • n=5 Participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score items 13-16	9.5 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score items 21-23	4.8 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score items 17-20	11.1 units on a scale STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: End of 12 week treatment period

Population: 4 subjects with missing values

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=102 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF). suitable or very suitable	73 participants
The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF). a little suitable	21 participants
The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF). not suitable at all	8 participants

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 3 subjects with missing values

Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=103 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4	8.8 MSTCQ Score (units on a scale) Standard Deviation 3.9

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 6 subjects with missing values

Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=100 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8	8.8 MSTCQ Score (units on a scale) Standard Deviation 3.8

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: Intention to treat population

Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12	9.0 MSTCQ Score (units on a scale) Standard Deviation 3.8

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 3 subjects with missing values

Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=103 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4	11.4 MSTCQ Score (units on a scale) Standard Deviation 3.2

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 6 subjects with missing values

Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=100 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8	11.3 MSTCQ Score (units on a scale) Standard Deviation 3.5

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: Intention to treat population

Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12	11.4 MSTCQ Score (units on a scale) Standard Deviation 3.4

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 3 subjects with missing values

Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=103 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4	5.5 MSTCQ Score (units on a scale) Standard Deviation 2.4

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 6 subjects with missing values

Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=100 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8	5.2 MSTCQ Score (units on a scale) Standard Deviation 2.2

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: Intention to treat population

Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12	5.6 MSTCQ Score (units on a scale) Standard Deviation 2.6

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 3 subjects with missing values

Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=103 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4	0.2 MSTCQ Score (units on a scale) Standard Deviation 2.5

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 5 subjects with missing values

Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=101 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8	0.1 MSTCQ Score (units on a scale) Standard Deviation 1.9

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: Intention to treat population

Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12	0.2 MSTCQ Score (units on a scale) Standard Deviation 2.0

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 21 subjects with missing values

Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=85 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4 fewer injection site reactions	13 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4 less injection pain	17 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4 fewer flu-like symptoms	9 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4 fewer physical side effects	5 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4 overall convenience	50 participants

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 21 subjects with missing values

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=85 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8 fewer flu-like symptoms	6 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8 fewer physical side effects	8 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8 overall convenience	59 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8 fewer injection site reactions	8 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8 less injection pain	13 participants

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: 21 subjects with missing values

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=85 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12 fewer injection site reactions	6 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12 less injection pain	11 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12 fewer flu-like symptoms	6 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12 fewer physical side effects	5 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12 overall convenience	63 participants

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 4 subjects with missing values

Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=102 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4	30.2 mm (on a scale) Standard Deviation 24.6

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 5 subjects with missing values

Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=101 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8	30.8 mm (on a scale) Standard Deviation 24.9

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: Intention to treat population

Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12	30.0 mm (on a scale) Standard Deviation 25.1

SECONDARY outcome

Timeframe: at the end of week 4 of treatment

Population: 5 subjects with missing values

Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=101 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4 No pain	18 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4 Mild	44 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4 Discomforting	26 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4 Distressing	11 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4 Horrible Excruciating	2 participants

SECONDARY outcome

Timeframe: at the end of week 8 of treatment

Population: 5 subjects with missing values

Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=101 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8 No pain	17 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8 Mild	46 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8 Discomforting	25 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8 Distressing	12 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8 Horrible Excruciating	1 participants

SECONDARY outcome

Timeframe: at the end of week 12 of treatment

Population: Intention to treat population

Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating

Outcome measures

Outcome measures
Measure	RebiSmart for Self-injection n=106 Participants Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12 No pain	18 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12 Mild	42 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12 Discomforting	31 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12 Distressing	11 participants
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12 Horrible Excruciating	4 participants

SECONDARY outcome

Timeframe: at the end of weeks 4, 8, and 12 of treatment

Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section

Outcome measures

Outcome data not reported

Adverse Events

RebiSmart for Self-injection

Serious events: 6 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RebiSmart for Self-injection n=106 participants at risk Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
General disorders Adverse drug reaction	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Hepatobiliary disorders Biliary colic	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Breast infection	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Vascular disorders Hypertensive crisis	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Cardiac disorders Myocardial disorders	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Injury, poisoning and procedural complications Seroma	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.

Other adverse events

Other adverse events
Measure	RebiSmart for Self-injection n=106 participants at risk Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
General disorders Adverse drug reaction	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 2/106 • Number of events 2 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Musculoskeletal and connective tissue disorders Back pain	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Borrelia infection	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Breast infection	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Bronchitis	2.8% 3/106 • Number of events 3 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Chills	2.8% 3/106 • Number of events 7 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Nervous system disorders Facial palsy	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Fatigue	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Gastroenteritis	1.9% 2/106 • Number of events 2 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Nervous system disorders Headache	11.3% 12/106 • Number of events 25 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Impaired healing	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Influenza	3.8% 4/106 • Number of events 4 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Infuenza like illness	20.8% 22/106 • Number of events 54 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Injection site erythema	1.9% 2/106 • Number of events 2 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Injection site extravasation	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Injection site irritation	1.9% 2/106 • Number of events 2 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Injection site pain	2.8% 3/106 • Number of events 3 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Nervous system disorders Monoparesis	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	0.94% 1/106 • Number of events 3 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Musculoskeletal and connective tissue disorders Myalgia	2.8% 3/106 • Number of events 5 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Nasopharyngitis	9.4% 10/106 • Number of events 15 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Musculoskeletal and connective tissue disorders Neck pain	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Nervous system disorders Neuralgia	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Otitis media acute	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 2/106 • Number of events 2 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Pharyngitis	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
General disorders Pyrexia	1.9% 2/106 • Number of events 2 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Respiratory tract infection	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Nervous system disorders Syncope vasovagal	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Upper respiratory tract infection	4.7% 5/106 • Number of events 6 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
Infections and infestations Vulvovaginal mycotic infection	0.94% 1/106 • Number of events 1 • The timeframe over which adverse events were collected was during the 12-week treatment period. Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.

Additional Information

Elisabetta Verdun di Cantogno

Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +41 22 414 4887

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60