Trial Outcomes & Findings for Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma (NCT NCT01781468)
NCT ID: NCT01781468
Last Updated: 2025-01-27
Results Overview
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
328 participants
Primary outcome timeframe
At 8 weeks
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
Arm I (150 mg Armodafinil)
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
110
|
109
|
|
Overall Study
COMPLETED
|
103
|
97
|
97
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
Baseline characteristics by cohort
| Measure |
Arm I (150 mg Armodafinil)
n=109 Participants
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=110 Participants
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=109 Participants
Patients receive placebo orally every day in the morning for 8 weeks.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 12.21 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
101 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
310 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
ECOG Performance Status
0
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
ECOG Performance Status
1
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
ECOG Performance Status
2
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
ECOG Performance Status
3
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 8 weeksPopulation: Participants who completed the study are included in this analysis.
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
Outcome measures
| Measure |
Arm I (150 mg Armodafinil)
n=103 Participants
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=97 Participants
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=97 Participants
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.
|
29 Participants
|
27 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Participants who completed the study are included in this analysis.
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
Outcome measures
| Measure |
Arm I (150 mg Armodafinil)
n=103 Participants
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=97 Participants
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=97 Participants
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks.
|
37 Participants
|
31 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Participants who completed the Symbol Digit Modalities Test at baseline and end of week 8 are included in this analysis.
The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean.
Outcome measures
| Measure |
Arm I (150 mg Armodafinil)
n=61 Participants
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=55 Participants
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=60 Participants
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8
|
0.0 units on a scale
Interval -1.6 to 2.5
|
0.3 units on a scale
Interval -3.4 to 2.5
|
0.0 units on a scale
Interval -3.4 to 4.9
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Participants with LASA data available at all specified time points are included in this analysis. The number analyzed in row differ from the Overall number of participants who completed the study due to missing data (i.e. participants did not complete the LASA at either week 4 and/or week 8 time point(s)).
Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales.
Outcome measures
| Measure |
Arm I (150 mg Armodafinil)
n=80 Participants
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=68 Participants
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=84 Participants
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8
Baseline to Week 4
|
2.0 units on a scale
Interval -23.0 to 31.0
|
0.5 units on a scale
Interval -25.0 to 29.0
|
2.0 units on a scale
Interval -10.0 to 26.0
|
|
Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8
Baseline to Week 8
|
4.0 units on a scale
Interval -32.0 to 26.0
|
3.0 units on a scale
Interval -16.0 to 27.0
|
2.0 units on a scale
Interval -15.0 to 27.0
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Participants who started the study are included in this analysis.
The number of participants who experienced at least one grade 3 or higher adverse events deemed at least possibly related to treatment via the CTCAE version 4.0
Outcome measures
| Measure |
Arm I (150 mg Armodafinil)
n=109 Participants
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=110 Participants
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=109 Participants
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0
|
6 Participants
|
8 Participants
|
3 Participants
|
Adverse Events
Arm I (150 mg Armodafinil)
Serious events: 12 serious events
Other events: 55 other events
Deaths: 0 deaths
Arm II (250 mg Armodafinil)
Serious events: 9 serious events
Other events: 60 other events
Deaths: 2 deaths
Arm III (Placebo)
Serious events: 8 serious events
Other events: 42 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm I (150 mg Armodafinil)
n=109 participants at risk
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=110 participants at risk
Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=109 participants at risk
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
General disorders
Fatigue
|
0.00%
0/109 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
2.7%
3/110 • Number of events 3 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Aphonia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Dizziness
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Edema cerebral
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Memory impairment
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Movements involuntary
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Seizure
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
|
Psychiatric disorders
Confusion
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
Other adverse events
| Measure |
Arm I (150 mg Armodafinil)
n=109 participants at risk
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
|
Arm II (250 mg Armodafinil)
n=110 participants at risk
Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks.
|
Arm III (Placebo)
n=109 participants at risk
Patients receive placebo orally every day in the morning for 8 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.6%
5/109 • Number of events 6 • Up to 8 weeks
|
3.6%
4/110 • Number of events 4 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
General disorders
Edema limbs
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
General disorders
Fatigue
|
8.3%
9/109 • Number of events 9 • Up to 8 weeks
|
6.4%
7/110 • Number of events 8 • Up to 8 weeks
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
|
General disorders
Gait disturbance
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
General disorders
Pain
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
|
Infections and infestations
Upper respiratory infection
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Investigations
GGT increased
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.92%
1/109 • Number of events 2 • Up to 8 weeks
|
|
Investigations
Neutrophil count decreased
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Investigations
Platelet count decreased
|
2.8%
3/109 • Number of events 3 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Investigations
White blood cell decreased
|
2.8%
3/109 • Number of events 3 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 2 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
3.6%
4/110 • Number of events 5 • Up to 8 weeks
|
0.92%
1/109 • Number of events 2 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Amnesia
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Ataxia
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Dizziness
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
4.5%
5/110 • Number of events 6 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/109 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/109 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Headache
|
38.5%
42/109 • Number of events 62 • Up to 8 weeks
|
41.8%
46/110 • Number of events 67 • Up to 8 weeks
|
32.1%
35/109 • Number of events 54 • Up to 8 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Seizure
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Psychiatric disorders
Confusion
|
0.00%
0/109 • Up to 8 weeks
|
1.8%
2/110 • Number of events 2 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/109 • Up to 8 weeks
|
1.8%
2/110 • Number of events 3 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/109 • Number of events 2 • Up to 8 weeks
|
6.4%
7/110 • Number of events 7 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Psychiatric disorders
Personality change
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/109 • Up to 8 weeks
|
1.8%
2/110 • Number of events 3 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Vascular disorders
Hypertension
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
1.8%
2/110 • Number of events 3 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/109 • Up to 8 weeks
|
0.00%
0/110 • Up to 8 weeks
|
0.92%
1/109 • Number of events 1 • Up to 8 weeks
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/109 • Up to 8 weeks
|
0.91%
1/110 • Number of events 1 • Up to 8 weeks
|
0.00%
0/109 • Up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place