Trial Outcomes & Findings for A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas (NCT NCT00766467)

NCT ID: NCT00766467

Last Updated: 2016-07-28

Results Overview

The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score \< 30 indicates severe fatigue.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: 43 days
• Results posted on: 2016-07-28

Participant Flow

Study activated at Dana-Farber Cancer Institute in August 2008 and was eventually activated at Beth Israel Medical Center , Dartmouth Hitchcock Medical Center, and University of California San Diego. The study closed to new accrual as of April 2014 as the accrual was met.

Randomization was performed by the Quality Assurance for Clinical Trials office at the Dana Farber Cancer Institute. Patients were randomized in a 1:1 basis to each treatment arm with no stratification.

Participant milestones

Measure	Armodafinil Armodafinil: 150mg taken orally once a day in the morning.	Placebo Placebo: Taken orally once a day in the morning
Overall Study STARTED	42	39
Overall Study Initiated Treatment	39	38
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Measure	Armodafinil Armodafinil: 150mg taken orally once a day in the morning.	Placebo Placebo: Taken orally once a day in the morning
Overall Study Withdrawal by Subject	7	2
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	2	4
Overall Study Tumor Progression on Study	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

Baseline characteristics by cohort

Measure	Armodafinil n=42 Participants Armodafinil: Taken orally once a day in the morning.	Placebo n=39 Participants Placebo: Taken orally once a day in the morning.	Total n=81 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	54 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Karnofsky Performance Status (KPS)	90 Units on a scale n=5 Participants	90 Units on a scale n=7 Participants	90 Units on a scale n=5 Participants
Glioma grade Grade 2	1 units on a scale n=5 Participants	4 units on a scale n=7 Participants	5 units on a scale n=5 Participants
Glioma grade Grade 3	14 units on a scale n=5 Participants	12 units on a scale n=7 Participants	26 units on a scale n=5 Participants
Glioma grade Grade 4	25 units on a scale n=5 Participants	22 units on a scale n=7 Participants	47 units on a scale n=5 Participants
Glioma grade Grade not defined	2 units on a scale n=5 Participants	1 units on a scale n=7 Participants	3 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 43 days

Population: Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.

The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.

Outcome measures

Measure	Armodafinil n=31 Participants Armodafinil: Taken orally once a day in the morning.	Placebo n=29 Participants Placebo: Taken orally once a day in the morning.
Change From Baseline in Fatigue at Day 43	-1 units on a scale Interval -22.0 to 48.0	-3 units on a scale Interval -38.0 to 22.0

SECONDARY outcome

Timeframe: baseline, day 22, day 43, and day 56

Population: Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.

The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.

Outcome measures

Measure	Armodafinil n=31 Participants Armodafinil: Taken orally once a day in the morning.	Placebo n=29 Participants Placebo: Taken orally once a day in the morning.
Change From Baseline in Quality of Life at Days 22, 43 and 56 FACIT-G (baseline vs day 22)	-1.76 units on a scale Interval -45.01 to 24.5	-4.94 units on a scale Interval -45.0 to 21.0
Change From Baseline in Quality of Life at Days 22, 43 and 56 FACIT-G (baseline vs day 43)	2.50 units on a scale Interval 0.28 to 25.17	-2.30 units on a scale Interval -58.6 to 20.17
Change From Baseline in Quality of Life at Days 22, 43 and 56 FACIT-G (baseline vs day 56)	1.83 units on a scale Interval -40.0 to 22.0	-0.84 units on a scale Interval -24.0 to 16.0

SECONDARY outcome

Timeframe: 56 days

Population: Grade 3 - 4 events at least possibly related to study treatment.

To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.

Outcome measures

Measure	Armodafinil n=42 Participants Armodafinil: Taken orally once a day in the morning.	Placebo n=39 Participants Placebo: Taken orally once a day in the morning.
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Abdominal pain	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Confusion	0 number of incidents	1 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Dehydration	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Diarrhea	1 number of incidents	1 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Glaucoma	0 number of incidents	1 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Hyperkalemia	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Hypokalemia	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Hypomagnesemia	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Ileus	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Insomnia	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Mood alteration (agitation)	0 number of incidents	1 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Obstruction, cecum	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Rash	0 number of incidents	1 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Seizure	1 number of incidents	0 number of incidents
Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment Speech impairment	0 number of incidents	1 number of incidents

Adverse Events

Armodafinil

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Armodafinil n=42 participants at risk Armodafinil: Taken orally once a day in the morning.	Placebo n=39 participants at risk Placebo: Taken orally once a day in the morning.
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression NOS	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Platelets	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Neutrophils	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Obstruction, Cecum	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Ileus	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Abdominal pain	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.

Other adverse events

Measure	Armodafinil n=42 participants at risk Armodafinil: Taken orally once a day in the morning.	Placebo n=39 participants at risk Placebo: Taken orally once a day in the morning.
Immune system disorders Allergic Reaction	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Ear and labyrinth disorders Hearing w/o audiogr not in monitor prg	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Ear and labyrinth disorders Otitis, external ear (non-infectious)	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Ear and labyrinth disorders Hearing-other	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Hemoglobin	7.1% 3/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Leukocytes	2.4% 1/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	12.8% 5/39 • Number of events 11 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Lymphopenia	2.4% 1/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 9 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Myelodysplasia	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Neutrophils	4.8% 2/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 9 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Platelets	4.8% 2/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 23 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Hematologic-other	4.8% 2/42 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	12.8% 5/39 • Number of events 13 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Cardiac disorders Heart block Wolff-Parkinson-White	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Cardiac disorders Hypotension	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Cardiac disorders Cardiac-other	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Fatigue	40.5% 17/42 • Number of events 20 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	38.5% 15/39 • Number of events 20 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Fever w/o neutropenia	4.8% 2/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Insomnia	31.0% 13/42 • Number of events 17 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	28.2% 11/39 • Number of events 15 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Rigors/chills	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Weight gain	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Constitutional, other	7.1% 3/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Coagulation-other	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Dry skin	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Pruritus/itching	4.8% 2/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Rash/desquamation	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	12.8% 5/39 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Radiation dermatitis	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Skin and subcutaneous tissue disorders Skin-other	9.5% 4/42 • Number of events 7 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Endocrine disorders Cushingnoid appearance	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Vascular disorders Hot flashes	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Metabolism and nutrition disorders Anorexia	14.3% 6/42 • Number of events 6 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	17.9% 7/39 • Number of events 7 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Constipation	23.8% 10/42 • Number of events 10 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	17.9% 7/39 • Number of events 8 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Metabolism and nutrition disorders Dehydration	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Teeth development	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Diarrhea w/o prior colostomy	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Dry mouth	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Dysphagia	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Gastritis	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Dyspepsia	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Hemorrhoids	2.4% 1/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Nausea	28.6% 12/42 • Number of events 17 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	28.2% 11/39 • Number of events 11 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Taste disturbance	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Vomiting	14.3% 6/42 • Number of events 6 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders GI-other	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations Infection w/ gr3-4 neut, oral cavity	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations Infection Gr0-2 neut, oral cavity	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations Infection Gr0-2 neut, paranasal	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations nfection Gr0-2 neut, urinary tract	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations nfection Gr0-2 neut, wound	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations Infection w/ unk ANC skin (cellulitis)	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Infections and infestations Infection-other	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Edema head and neck	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Edema limb	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Blood and lymphatic system disorders Lymphatics-other	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations ALT, SGPT	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations AST, SGOT	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hypercalcemia	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hyperglycemia	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 6 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hypoglycemia	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Lipase	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hypomagnesemia	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hyperkalemia	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hypokalemia	2.4% 1/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Hyponatremia	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Investigations Metabolic/Laboratory-other	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Arthritis	2.4% 1/42 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Extremity-lower (gait/walking)	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Nonneuropathic lower extr muscle weakness	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Nonneuropathic upper extr muscle weakness	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Nonneuropathic left-side muscle weakness	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	4.8% 2/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders CNS necrosis/cystic progression	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Cognitive disturbance	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Confusion	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Dizziness	16.7% 7/42 • Number of events 9 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	15.4% 6/39 • Number of events 7 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Memory impairment	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Psychiatric disorders Agitation	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Psychiatric disorders Anxiety	28.6% 12/42 • Number of events 13 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Psychiatric disorders Depression	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Neuropathy CN II vision	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Neuropathy CN V jaw / face-sensory	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Neuropathy-motor	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Neuropathy-sensory	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Seizure	4.8% 2/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Speech impairment	4.8% 2/42 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Tremor	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Neurologic-other	7.1% 3/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	17.9% 7/39 • Number of events 7 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Eye disorders Dry eye syndrome	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Eye disorders Glaucoma	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Eye disorders Vision-blurred	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Eye disorders Ocular-other	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Abdomen, pain	7.1% 3/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Back, pain	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Gastrointestinal disorders Dental/teeth/peridontal, pain	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Dental/teeth/peridontal, pain	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	10.3% 4/39 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Nervous system disorders Headache	35.7% 15/42 • Number of events 23 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	28.2% 11/39 • Number of events 13 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Joint, pain	4.8% 2/42 • Number of events 4 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Muscle, pain	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 5 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Musculoskeletal and connective tissue disorders Neck, pain	2.4% 1/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	5.1% 2/39 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
General disorders Pain- other	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/42 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/42 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Renal and urinary disorders Urinary frequency/urgency	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	7.7% 3/39 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Renal and urinary disorders Renal - other	4.8% 2/42 • Number of events 2 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	0.00% 0/39 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	7.1% 3/42 • Number of events 3 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.	2.6% 1/39 • Number of events 1 • Adverse events were collected on each participant from the time armodafinil/placebo was started up to Day 56 contact. Abnormal laboratory values or diagnostic tests results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests.

Additional Information

Eudocia Quant Lee, MD

Dana-Farber Cancer Insitute

Phone: 617-632-2166

Email: eqlee@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60