Trial Outcomes & Findings for A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS (NCT NCT02208050)

NCT ID: NCT02208050

Last Updated: 2021-07-09

Results Overview

9 Hole Peg Test is a test of upper limb function. Participants place 9 pegs on pegboard and remove pegs - this is timed for each hand. Time recorded in seconds. Longer time indicates poorer upper limb function. 20% improvement is defined as 20% shorter time in seconds. An upper limb responder is defined as a patient with both of the two "on treatment" 9 Hole Peg Test (9-HPT) assessments measured in seconds (assessments 4 \& 5 or 7 \& 8) improving 20% from the average of the baseline assessments (1, 2 \& 3). Washout assessment not included in the analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

20 weeks. Baseline assessments 1,2,3: weeks 0-2. Assessment 4 - midway through first treatment period; assessment 5: end of first treatment period. Assessment 7: midway through second treatment period, assessment 8: end of second treatment period.

Results posted on

2021-07-09

Participant Flow

The study recruited male and female patients between the ages of 18 - 70 years with clinically definite primary or secondary progressive multiple sclerosis, between 2013 and 2015. After recruitment and randomisation, three baseline assessments occurred over two weeks. Patients were then treated with fampridine-washout-placebo or placebo-washout-fampridine for 8 weeks followed by a 2 week washout and then cross-over to the other arm for 8 weeks followed by a 2 week washout.

Participant milestones

Participant milestones
Measure	Group A: Fampridine Followed by Placebo Participants who received fampridine first before crossing over to the placebo arm. Following baseline assessment and randomisation, participants received 10mg pr-fampridine twice daily for eight weeks followed by a two week washout period and then received placebo tablet twice daily for ten weeks.	Group B: Placebo Followed by Fampridine Participants who received placebo first before crossing over to fampridine. After baseline assessment and randomisation, participants received placebo twice daily for 8 weeks, then had a 2 week washout period, followed by 8 weeks of treatment with 10mg pr-fampridine.
Baseline Assessment Period: 2 Weeks STARTED	36	28
Baseline Assessment Period: 2 Weeks COMPLETED	36	28
Baseline Assessment Period: 2 Weeks NOT COMPLETED	0	0
Treatment Period 1: 8 Weeks Treatment STARTED	36	28
Treatment Period 1: 8 Weeks Treatment COMPLETED	36	28
Treatment Period 1: 8 Weeks Treatment NOT COMPLETED	0	0
Washout Period 1: 2 Weeks STARTED	36	28
Washout Period 1: 2 Weeks COMPLETED	35	28
Washout Period 1: 2 Weeks NOT COMPLETED	1	0
Treatment Period 2: 8 Weeks Treatment STARTED	35	28
Treatment Period 2: 8 Weeks Treatment COMPLETED	33	28
Treatment Period 2: 8 Weeks Treatment NOT COMPLETED	2	0
Washout Period 2: 2 Weeks Washout. STARTED	33	28
Washout Period 2: 2 Weeks Washout. COMPLETED	33	28
Washout Period 2: 2 Weeks Washout. NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: Fampridine Followed by Placebo Participants who received fampridine first before crossing over to the placebo arm. Following baseline assessment and randomisation, participants received 10mg pr-fampridine twice daily for eight weeks followed by a two week washout period and then received placebo tablet twice daily for ten weeks.	Group B: Placebo Followed by Fampridine Participants who received placebo first before crossing over to fampridine. After baseline assessment and randomisation, participants received placebo twice daily for 8 weeks, then had a 2 week washout period, followed by 8 weeks of treatment with 10mg pr-fampridine.
Washout Period 1: 2 Weeks Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Fampridine Followed by Placebo n=36 Participants Patients will be randomised to a 8 week treatment period with the active drug followed by a 2 week washout period before an 8 week treatment period with placebo. Fampridine Placebo	Group 2: Placebo Followed by Fampridine n=28 Participants Patients will be randomised to a 8 week treatment period with the placebo, followed by a 2 week washout period and a further 8 week treatment period with the active drug. Fampridine Placebo	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=36 Participants	0 Participants n=28 Participants	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=36 Participants	25 Participants n=28 Participants	58 Participants n=64 Participants
Age, Categorical >=65 years	3 Participants n=36 Participants	3 Participants n=28 Participants	6 Participants n=64 Participants
Age, Continuous	55.1 years n=36 Participants	53.7 years n=28 Participants	55.1 years n=64 Participants
Sex: Female, Male Sex · Female	23 Participants n=36 Participants	15 Participants n=28 Participants	38 Participants n=64 Participants
Sex: Female, Male Sex · Male	13 Participants n=36 Participants	13 Participants n=28 Participants	26 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Ireland	36 participants n=36 Participants	28 participants n=28 Participants	64 participants n=64 Participants
Multiple Sclerosis (MS) Subtype Secondary Progressive MS (SPMS)	23 Participants n=36 Participants	22 Participants n=28 Participants	45 Participants n=64 Participants
Multiple Sclerosis (MS) Subtype Primary Progressive MS (PPMS)	13 Participants n=36 Participants	5 Participants n=28 Participants	18 Participants n=64 Participants
Multiple Sclerosis (MS) Subtype Unknown	0 Participants n=36 Participants	1 Participants n=28 Participants	1 Participants n=64 Participants
On Disease Modifying Treatment (DMT)	12 Participants n=36 Participants	13 Participants n=28 Participants	25 Participants n=64 Participants
EDSS (Expanded Disability Status Scale)	6 units on a scale n=36 Participants	6 units on a scale n=28 Participants	6 units on a scale n=64 Participants
Disease Duration	15.7 years n=36 Participants	19.2 years n=28 Participants	16.8 years n=64 Participants
Baclofen	4 participants n=36 Participants	4 participants n=28 Participants	8 participants n=64 Participants
Tizanadine	3 Participants n=36 Participants	1 Participants n=28 Participants	4 Participants n=64 Participants
Benzodiazepine	0 Participants n=36 Participants	1 Participants n=28 Participants	1 Participants n=64 Participants

PRIMARY outcome

Timeframe: 20 weeks. Baseline assessments 1,2,3: weeks 0-2. Assessment 4 - midway through first treatment period; assessment 5: end of first treatment period. Assessment 7: midway through second treatment period, assessment 8: end of second treatment period.

Population: Analysis population included all participants who received treatment and placebo for eight weeks. Two participants withdrew during the second 8-week treatment period and were not included in the final analysis.

Outcome measures

Outcome measures
Measure	PR-Fampridine n=62 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=62 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 MSIS-9 scores during treatment with placebo.
Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) Non-dominant hand · Non-responders	60 Participants	61 Participants	—	—
Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) Dominant hand · Responders	4 Participants	3 Participants	—	—
Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) Dominant hand · Non-responders	58 Participants	59 Participants	—	—
Number of Participants Classified as Upper Limb Responders on the 9 Hole Peg Test (9HPT) Non-dominant hand · Responders	2 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8

Population: Participants who had completed assessments at the above time points to allow analysis.

Jebsen Taylor Hand Function Test (JTT) is a timed test (seconds) comprising of seven 'real-world' tasks such as picking up small items. It has been validated for use in upper limb function in MS. A secondary measure of upper limb responsiveness will be defined as number of participants with a 20% improvement in from baseline in the average time taken to complete all seven tasks on the Jebsen Taylor Hand Function Test "on treatment" (assessments 4 \& 5 or 7 \& 8) compared with baseline assessments (assessments 1,2 \& 3). Baseline assessments (1,2,3) performed in two week period prior to first treatment block. Longer time indicates worse functioning. Improvement is defined as shorter time in seconds. Assessment 4: Midway through first treatment period (week 4 of 8 week treatment period) Assessment 5: End of first treatment period (end of week 8) Assessment 7: Midway through second treatment period Assessment 8: End of second treatment period

Outcome measures

Outcome measures
Measure	PR-Fampridine n=63 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=61 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 MSIS-9 scores during treatment with placebo.
Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) Dominant hand · Responders	3 Participants	0 Participants	—	—
Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) Non-dominant hand · Responders	3 Participants	0 Participants	—	—
Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) Dominant hand · Non-responders	60 Participants	61 Participants	—	—
Number of Participants Defined as Upper Limb Responders on the Jebsen Taylor Hand Function Test (JTT) Non-dominant hand · Non-responders	60 Participants	61 Participants	—	—

SECONDARY outcome

Timeframe: 20 weeks: Weeks 0-2: Assessment 1/2/3; Week 6: Assessment 4; Week 10: Assessment 5; Week 16: Assessment 7; Week 20: Assessment 8

Population: Population with 25 foot walk data on analysis of results.

A mobility responder to Fampridine will be defined as a patient with both of the two "on treatment" T25FW assessments (assessments 4 \& 5 or 7 \& 8) being better (shorter time in seconds) than the maximum of any of the four "off treatment" assessments (assessments 1, 2, 3, 6). Otherwise the patient will be deemed a non-responder. T25FW test is the time taken to walk 25 feet taken as the average of two trials. Measured in seconds. Longer time indicates slower walking. Improvement is considered shorter amount of time in seconds - no specific percentage or amount of time was considered necessary. Assessment 4: Midway through first treatment period (week 4 of 8 week treatment period) Assessment 5: End of first treatment period (end of week 8) Assessment 7: Midway through second treatment period Assessment 8: End of second treatment period.

Outcome measures

Outcome measures
Measure	PR-Fampridine n=61 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=61 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 MSIS-9 scores during treatment with placebo.
The Number of Mobility Responders to Fampridine as Measured by an Improvement in the 25 Foot Timed Walk (T25FW) Responders	59 Participants	59 Participants	—	—
The Number of Mobility Responders to Fampridine as Measured by an Improvement in the 25 Foot Timed Walk (T25FW) Non-responders	2 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 20 weeks: Assessments at Week 6 - midway through first treatment period, Week 10 - end of first treatment period, Week 16 - midway through second treatment period, Week 20 - end of second treatment period.

Population: Mean scores in the DASH for all participants in the trial during on treatment periods (assessments 4\&5; 7\&8).

Disabilities of the Arm Shoulder and Hand Scores questionnaire: The DASH consists of a 30-item disability symptom scale scored 0 (no disability) to 100, developed as a self-rated upper extremity disability and symptoms. Higher scores indicate higher self-perception of disability. DASH questionnaire administered to fampridine treated group at Weeks 6,10,16 and 20. Scores at each time point were summed and averaged. DASH questionnaire administered to placebo treated group at Weeks 6,10,16 and 20. Scores at each time point were summed and averaged.

Outcome measures

Outcome measures
Measure	PR-Fampridine n=63 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=63 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 MSIS-9 scores during treatment with placebo.
Mean Scores in DASH - Fampridine and Placebo.	35.4 Mean units on a scale. Standard Deviation 19.5	38.3 Mean units on a scale. Standard Deviation 20.5	—	—

SECONDARY outcome

Population: Participants on treatment with Fampridine or Placebo.

Multiple Sclerosis Walking Scale 12 is a 12-item self report measure of the impact of MS on an individual's walking ability. Scores are summed 1-3; 1-5 for each item. Higher scores indicate higher limitation in walking ability. Scores are summed and transformed to a 0-100 scale again with higher scores indicating higher self-reported limitation in walking ability. MSWS12 scores were collected for the group on Placebo treatment at Weeks 6,10,16 and 20 - the sum of the 4 scores was averaged. MSWS-12 scores were collected for the group on Fampridine treatment at Weeks 6, 10, 16, 20. The sum of the 4 scores was averaged.

Outcome measures

Outcome measures
Measure	PR-Fampridine n=62 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=62 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 MSIS-9 scores during treatment with placebo.
Mean Scores in Multiple Sclerosis Walking Scale (MSWS-12) - Fampridine and Placebo.	64.5 units on a scale Standard Deviation 28.2	65 units on a scale Standard Deviation 27	—	—

SECONDARY outcome

Population: Mean scores on AMSQ during on-treatment period. (AMSQ assessments 4 \& 5, 7 \& 8).

AMSQ - Arm Function in Multiple Sclerosis Questionnaire. This is a 31-item patient reported outcome measure which is validated to measure limitation in arm and hand functioning in people with multiple sclerosis. Patients rate the ability to which they can perform routine daily tasks with current hand function. Higher scores indicate greater limitations. Scale ranges from 0-100. AMSQ scores were collected for the group on Placebo treatment at Weeks 6,10,16 and 20 - the sum of the 4 scores was averaged. AMSQ scores were collected for the group on Fampridine treatment at Weeks 6, 10, 16, 20. The sum of the 4 scores was averaged.

Outcome measures

Outcome measures
Measure	PR-Fampridine n=62 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=62 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 MSIS-9 scores during treatment with placebo.
Mean Scores in the Disabilities in Arm Function in Multiple Sclerosis Questionnaire (AMSQ) Score Between Fampridine and Placebo.	35.4 units on a scale Standard Deviation 19.8	38.4 units on a scale Standard Deviation 21.5	—	—

SECONDARY outcome

Population: Participants during on-treatment period with fampridine or placebo.

MSIS-29 is a patient reported outcome with a physical and psychological component combined into one scale. They refer to the self-reported impact of MS on their physical and psychological wellbeing. Higher scores indicate a higher impact on functioning. The 20 item physical scale and the 9 item psychological scale are reported as two separate scaled scores. Both scale ranges are 0-100. Higher scores indicate a higher impact on functioning. MSIS -20 and MSIS-9 scores were collected for the group on Placebo treatment at Weeks 6,10,16 and 20 - the sum of the scores was averaged. MMSIS-20 and MSIS-9 scores were collected for the group on Fampridine treatment at Weeks 6, 10, 16, 20. The sum of the scores was averaged.

Outcome measures

Outcome measures
Measure	PR-Fampridine n=62 Participants 10mg fampridine twice daily for 8 weeks.	Placebo n=62 Participants Placebo tablets twice daily for 8 weeks.	Fampridine: MSIS-9 n=62 Participants MSIS-9 scores during treatment with fampridine	Placebo: MSIS-9 n=62 Participants MSIS-9 scores during treatment with placebo.
Mean Scores of MSIS-29 - Fampridine and Placebo	42.4 units on a scale Standard Deviation 22	43.3 units on a scale Standard Deviation 24	30.5 units on a scale Standard Deviation 22	29.4 units on a scale Standard Deviation 21

Adverse Events

Fampridine

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Professor Christopher McGuigan

St. Vincent's University Hospital

Phone: +35312214209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fampridine n=64 participants at risk Adverse events reported by the patients when treated with Fampridine	Placebo n=64 participants at risk Adverse events reported by the patients when treated with placebo.
Vascular disorders Peripheral venous disease	1.6% 1/64 • Number of events 1 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Injury, poisoning and procedural complications Laceration to Foot	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Injury, poisoning and procedural complications Fall	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Investigations Elevated hepatic enzymes	4.7% 3/64 • Adverse event data was collected for each participant for the study period (22 weeks).	6.2% 4/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Respiratory, thoracic and mediastinal disorders Cough	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Blood and lymphatic system disorders Lymphopenia	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Dizziness	7.8% 5/64 • Adverse event data was collected for each participant for the study period (22 weeks).	6.2% 4/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Headache	10.9% 7/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Worsening hemiparesis	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Muscle Spasticity	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Numbness	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Tremor	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Nervous system disorders Syncope	4.7% 3/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
General disorders Influenza like illness	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
General disorders Fatigue	4.7% 3/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
General disorders Insomnia	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
General disorders Weakness	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Ear and labyrinth disorders Vertigo	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Gastrointestinal disorders Nausea	6.2% 4/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Gastrointestinal disorders Vomiting	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Gastrointestinal disorders Diarrhoea	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Gastrointestinal disorders Constipation	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Skin and subcutaneous tissue disorders Rash	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Musculoskeletal and connective tissue disorders Mobility	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	4.7% 3/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Musculoskeletal and connective tissue disorders Muscular pain	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Musculoskeletal and connective tissue disorders Pain extremity	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	4.7% 3/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Musculoskeletal and connective tissue disorders Hip Pain	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Cellulitis	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Ear Infection	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Gastroenteritis	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Urinary Tract Infection	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	4.7% 3/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Sinusitis	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Upper Respiratory Tract Infection	7.8% 5/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Lower Respiratory Tract Infection	3.1% 2/64 • Adverse event data was collected for each participant for the study period (22 weeks).	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).
Infections and infestations Influenza	1.6% 1/64 • Adverse event data was collected for each participant for the study period (22 weeks).	0.00% 0/64 • Adverse event data was collected for each participant for the study period (22 weeks).