Trial Outcomes & Findings for BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis (NCT NCT02110706)
NCT ID: NCT02110706
Last Updated: 2020-03-06
Results Overview
Percent of subjects that achieve a ≥ 75% reduction in mean daily prednisone dose in the 4 weeks prior to week 52 and have clinical improvement or no significant worsening of symptoms (≤ 2 point increase in MGC score) as compared to 4-week period prior to randomization and initiation of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
4 weeks prior baseline and 4 weeks prior to week 52
Results posted on
2020-03-06
Participant Flow
68 study participants were consented and assessed for eligibility. 14 participants were ineligible. 2 participants declined. 52 study participants were randomized.
Participant milestones
| Measure |
Rituximab
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo Group
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
No. Completing Study Through Week 52
|
23
|
24
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Rituximab
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo Group
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Patients who didn't receive 2nd infusion
|
3
|
1
|
Baseline Characteristics
BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Rituximab
n=25 Participants
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo
n=27 Participants
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · African American
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Hispanic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Non-Hispanic white
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Baseline Prednisone Dose
|
23 mg/day
STANDARD_DEVIATION 11.2 • n=5 Participants
|
21.3 mg/day
STANDARD_DEVIATION 8.3 • n=7 Participants
|
22.1 mg/day
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Baseline Myasthenia Gravis Composite (MGC)
|
11.1 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
8.5 units on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Baseline Quantitative Myasthenia Gravis (QMG)
|
11.0 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Baseline MG-Activities of Daily Living Score
|
5.8 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Baseline MG-Quality of Life (MG-QOL) score
|
22.7 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 10.6 • n=7 Participants
|
20.1 units on a scale
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Baseline MGFA Clinical Classification Grade
Class I
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline MGFA Clinical Classification Grade
Class II
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Baseline MGFA Clinical Classification Grade
Class III
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Baseline MGFA Clinical Classification Grade
Class IV
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Thymectomy
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks prior baseline and 4 weeks prior to week 52Population: Intention to treat participants
Percent of subjects that achieve a ≥ 75% reduction in mean daily prednisone dose in the 4 weeks prior to week 52 and have clinical improvement or no significant worsening of symptoms (≤ 2 point increase in MGC score) as compared to 4-week period prior to randomization and initiation of treatment.
Outcome measures
| Measure |
Rituximab
n=25 Participants
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo
n=27 Participants
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Steroid Sparing Effect
|
15 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intention to treat participants
Evaluate treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Outcome measures
| Measure |
Rituximab
n=25 Participants
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo
n=27 Participants
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Safety:Percentage of Study Participants With Treatment-related Adverse Experiences
% of participants with treatment related AEs
|
19 Participants
|
22 Participants
|
|
Safety:Percentage of Study Participants With Treatment-related Adverse Experiences
% participants with treatment related SAEs
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: Intention to treat participants
Evaluate whether there is a trend towards clinical benefit at end of 52 week treatment period, as measured by mean change in the MGC score, an MG-specific clinical outcomes scale used as endpoint in prior MG clinical trials. The Myasthenia Gravis Composite (MGC) scale consists of test items from the MG-ADL (Myasthenia Gravis Activities of Daily Living) scale and the QMG (Quantitative Myasthenia Gravis Scale) that measure symptoms and signs of MG, with weighted response options. The minimum score is 0, and the maximum score is 50. Higher scores correlate with clinical worsening of the disease.
Outcome measures
| Measure |
Rituximab
n=25 Participants
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo
n=27 Participants
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Change in Myasthenia Gravis Composite (MGC) Scores From Baseline to Week 52
|
-5.7 score on a scale
Standard Deviation 7.26
|
-4.0 score on a scale
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: Intention to treat participants
Evaluate whether there is a trend towards clinical benefit at end of 52 week treatment period, as measured by the mean change in the QMG score - a specific clinical outcome scale used as endpoint in prior MG clinical trials. The Quantitative Myasthenia Gravis Score (QMG) is a commonly used objective outcome measure in myasthenia gravis (MG) comprising 13 items, each with a possible score from 0 to 3, and a maximum possible of 39 points, where a higher score indicates more severe disease.
Outcome measures
| Measure |
Rituximab
n=25 Participants
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo
n=27 Participants
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Change in Quantitative Myasthenia Gravis(QMG) Scores From Baseline to Week 52
|
-3.95 score on a scale
Standard Deviation 5.43
|
-1.70 score on a scale
Standard Deviation 3.91
|
Adverse Events
Rituximab
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo Group
Serious events: 14 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=25 participants at risk
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo Group
n=27 participants at risk
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Nervous system disorders
Worsening of MG
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
11.1%
3/27 • Number of events 4 • 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
General disorders
Chest pain
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Immune system disorders
Hypersensitivity
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Infections and infestations
Abscess neck
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Diverticulitis
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Septic shock
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Surgical and medical procedures
Micrographic skin surgery
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Vascular disorders
Thrombosis
|
0.00%
0/25 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
Other adverse events
| Measure |
Rituximab
n=25 participants at risk
\- Treatment group received two cycles of rituximab (375mg/m2 iv), separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
Placebo Group
n=27 participants at risk
\- Placebo group received infusion containing only vehicle components of rituximab solution. Infusion was done in 2 cycles, separated by 6 months. Each cycle defined as one infusion per week for four consecutive weeks. For the main study, participants were followed for 52 weeks. Study participants had clinical evaluations performed by a blinded evaluator at baseline and every 4 weeks thereafter.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Eye disorders
Vision blurred
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
3/25 • Number of events 4 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 3 • 52 weeks
|
22.2%
6/27 • Number of events 10 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
General disorders
Fatigue
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
29.6%
8/27 • Number of events 9 • 52 weeks
|
|
General disorders
Influenza like illness
|
12.0%
3/25 • Number of events 4 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
General disorders
Oedema peripheral
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
7.4%
2/27 • Number of events 3 • 52 weeks
|
|
Gastrointestinal disorders
Pyrexia
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Immune system disorders
Hypersensitivity
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
11.1%
3/27 • Number of events 4 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • 52 weeks
|
11.1%
3/27 • Number of events 3 • 52 weeks
|
|
Infections and infestations
Oral candidiasis
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Rhinitis
|
8.0%
2/25 • Number of events 3 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
11.1%
3/27 • Number of events 4 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
36.0%
9/25 • Number of events 12 • 52 weeks
|
18.5%
5/27 • Number of events 5 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
11.1%
3/27 • Number of events 5 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25 • 52 weeks
|
11.1%
3/27 • Number of events 3 • 52 weeks
|
|
Investigations
Weight increased
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.0%
6/25 • Number of events 6 • 52 weeks
|
37.0%
10/27 • Number of events 15 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
33.3%
9/27 • Number of events 11 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.0%
4/25 • Number of events 4 • 52 weeks
|
11.1%
3/27 • Number of events 4 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Number of events 2 • 52 weeks
|
14.8%
4/27 • Number of events 5 • 52 weeks
|
|
Injury, poisoning and procedural complications
Neck pain
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
14.8%
4/27 • Number of events 9 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Headache
|
32.0%
8/25 • Number of events 11 • 52 weeks
|
25.9%
7/27 • Number of events 13 • 52 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25 • 52 weeks
|
18.5%
5/27 • Number of events 7 • 52 weeks
|
|
Nervous system disorders
Tremor
|
8.0%
2/25 • Number of events 3 • 52 weeks
|
11.1%
3/27 • Number of events 4 • 52 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • 52 weeks
|
11.1%
3/27 • Number of events 3 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 3 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
3/25 • Number of events 3 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25 • Number of events 1 • 52 weeks
|
11.1%
3/27 • Number of events 3 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 3 • 52 weeks
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/25 • 52 weeks
|
7.4%
2/27 • Number of events 2 • 52 weeks
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
General disorders
Injection site reaction
|
8.0%
2/25 • Number of events 3 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
|
Infections and infestations
Fungal skin infection
|
8.0%
2/25 • Number of events 2 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place