Trial Outcomes & Findings for Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors (NCT NCT01032200)
NCT ID: NCT01032200
Last Updated: 2021-09-28
Results Overview
Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
4 weeks post-RT (approximately 3 months post randomization)
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Arm I - Armodafinil
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Arm I - Armodafinil
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Toxicity
|
0
|
2
|
|
Overall Study
Progression
|
1
|
0
|
|
Overall Study
Multiple
|
1
|
1
|
Baseline Characteristics
Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
Baseline characteristics by cohort
| Measure |
Arm I - Armodafinil
n=26 Participants
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=28 Participants
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-RT (approximately 3 months post randomization)Population: All randomized participants
Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.
Outcome measures
| Measure |
Arm I - Armodafinil
n=26 Participants
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=28 Participants
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Retention
|
85 percentage of participants
|
75 percentage of participants
|
PRIMARY outcome
Timeframe: 4 weeks post-RT (approximately 3 months post randomization)Population: Participants who returned pill diaries
Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)
Outcome measures
| Measure |
Arm I - Armodafinil
n=22 Participants
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=25 Participants
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Adherence
|
92.6 percentage of ideal number of pills
Interval 0.0 to 100.0
|
95.7 percentage of ideal number of pills
Interval 70.3 to 100.0
|
SECONDARY outcome
Timeframe: 4 weeks post-RTPopulation: Participants with any data
Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.
Outcome measures
| Measure |
Arm I - Armodafinil
n=26 Participants
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=27 Participants
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Fatigue
|
32.4 units on a scale
Standard Error 2.6
|
36.4 units on a scale
Standard Error 2.5
|
SECONDARY outcome
Timeframe: 4 weeks post-RTPopulation: Participants with any data
Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.
Outcome measures
| Measure |
Arm I - Armodafinil
n=26 Participants
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=27 Participants
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Sleepiness
|
7.2 units on a scale
Standard Error 1.0
|
8.3 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 4 weeks post-RTPopulation: Participants with any data
HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.
Outcome measures
| Measure |
Arm I - Armodafinil
n=26 Participants
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=27 Participants
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
HVLT-IR
|
21.2 number of correctly recalled words
Standard Error 1.5
|
20.0 number of correctly recalled words
Standard Error 1.4
|
Adverse Events
Arm I - Armodafinil
Serious events: 10 serious events
Other events: 26 other events
Deaths: 1 deaths
Arm II - Placebo
Serious events: 8 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I - Armodafinil
n=26 participants at risk
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=27 participants at risk
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Agitation
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Hepatobiliary disorders
Alanine Aminotransferase Increased
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Cardiac disorders
Chest Pain
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Confusion
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Death NOS
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Delirium
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Fall
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Fatigue
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Cardiac disorders
Hypertension
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Infections and infestations
Infections and Infestations - Other
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Infections and infestations
Lung Infection
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - left-sided
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - lower limb
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Eye disorders
Optic Nerve Disorder
|
3.8%
1/26 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Pain
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Personality Change
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Eye disorders
photophobia
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Vascular disorders
Stroke
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Vascular disorders
Thromboembolic Event
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
3.7%
1/27 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
Other adverse events
| Measure |
Arm I - Armodafinil
n=26 participants at risk
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Armodafinil: Given orally
|
Arm II - Placebo
n=27 participants at risk
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.2%
5/26 • Number of events 11 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
22.2%
6/27 • Number of events 15 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Anxiety
|
57.7%
15/26 • Number of events 55 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
37.0%
10/27 • Number of events 39 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
3/26 • Number of events 6 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
25.9%
7/27 • Number of events 18 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Back Pain
|
7.7%
2/26 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
11.1%
3/27 • Number of events 7 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Eye disorders
Blurred Vision
|
15.4%
4/26 • Number of events 11 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Cognitive Disturbance
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 10 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Confusion
|
11.5%
3/26 • Number of events 21 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
4/26 • Number of events 6 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
14.8%
4/27 • Number of events 7 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Radiation
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 4 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
11.1%
3/27 • Number of events 4 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Ear and labyrinth disorders
Dizziness
|
34.6%
9/26 • Number of events 24 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
29.6%
8/27 • Number of events 32 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Dry Mouth
|
34.6%
9/26 • Number of events 32 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
33.3%
9/27 • Number of events 45 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
2/26 • Number of events 7 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Ear and labyrinth disorders
Ear and Labyrinth - Other
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Edema Limbs
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Eye disorders
Eye Disorders - Other
|
19.2%
5/26 • Number of events 15 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Fatigue
|
65.4%
17/26 • Number of events 95 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
63.0%
17/27 • Number of events 71 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Gait Disturbance
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
11.1%
3/27 • Number of events 8 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Headache
|
73.1%
19/26 • Number of events 93 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
59.3%
16/27 • Number of events 53 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Cardiac disorders
Hypertension
|
11.5%
3/26 • Number of events 7 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
18.5%
5/27 • Number of events 21 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Insomnia
|
46.2%
12/26 • Number of events 46 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
51.9%
14/27 • Number of events 63 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Investigations
Investigations - Other
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Localized Edema
|
7.7%
2/26 • Number of events 12 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
11.1%
3/27 • Number of events 15 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Psychiatric disorders
Memory Impairment
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
18.5%
5/27 • Number of events 17 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Infections and infestations
Mucosal Infection
|
15.4%
4/26 • Number of events 16 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
12/26 • Number of events 35 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
48.1%
13/27 • Number of events 23 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
General disorders
Pain
|
11.5%
3/26 • Number of events 10 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
2/26 • Number of events 7 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Skin and subcutaneous tissue disorders
Rash Masculo-Papular
|
26.9%
7/26 • Number of events 15 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
11.1%
3/27 • Number of events 3 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 2 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
23.1%
6/26 • Number of events 9 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
18.5%
5/27 • Number of events 5 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Vascular disorders
Thromboembolic Event
|
11.5%
3/26 • Number of events 6 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
0.00%
0/27 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Nervous system disorders
Tremor
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 11 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
7.7%
2/26 • Number of events 7 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
11.1%
3/27 • Number of events 5 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/26 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
7.4%
2/27 • Number of events 8 • 3 months
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60