Trial Outcomes & Findings for A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma (NCT NCT01160380)
NCT ID: NCT01160380
Last Updated: 2014-11-06
Results Overview
Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Day 1, Day 28 and Day 56
Results posted on
2014-11-06
Participant Flow
Participant milestones
| Measure |
Armodafinil
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
67 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
65 years
STANDARD_DEVIATION 2.1 • 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
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 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
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group)
0
|
5 paarticipants
n=5 Participants
|
7 paarticipants
n=7 Participants
|
12 paarticipants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group)
1
|
18 paarticipants
n=5 Participants
|
17 paarticipants
n=7 Participants
|
35 paarticipants
n=5 Participants
|
|
ECOG (Eastern Cooperative Oncology Group)
2
|
2 paarticipants
n=5 Participants
|
1 paarticipants
n=7 Participants
|
3 paarticipants
n=5 Participants
|
|
Fatigue (baseline)-Brief Fatigue Inventory (BFI)
|
59 units on a scale
n=5 Participants
|
60.5 units on a scale
n=7 Participants
|
60 units on a scale
n=5 Participants
|
|
Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10)
|
9 units on a scale
n=5 Participants
|
9 units on a scale
n=7 Participants
|
9 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 56Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
BFI Score
Day 1(n=18, 23)
|
65.0 units on a scale
Standard Deviation 13.2
|
57.2 units on a scale
Standard Deviation 14.3
|
|
BFI Score
Day 28 (n=19, 23)
|
48.8 units on a scale
Standard Deviation 22.4
|
41.5 units on a scale
Standard Deviation 18.4
|
|
BFI Score
Day 56 (n=15)
|
43.2 units on a scale
Standard Deviation 18.9
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 56Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned. The test evaluates the time to correctly order letters and numbers; low times = better performance.
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Trail Making Test B Score (TMT-B)
Day 1(n=18, 23)
|
161.3 seconds
Standard Deviation 77.8
|
220.5 seconds
Standard Deviation 163.2
|
|
Trail Making Test B Score (TMT-B)
Day 28 (n=19, 23)
|
158.4 seconds
Standard Deviation 81.2
|
159.8 seconds
Standard Deviation 94.2
|
|
Trail Making Test B Score (TMT-B)
Day 56 (n=15)
|
153.8 seconds
Standard Deviation 78.7
|
NA seconds
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 56Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Symbol Digit Modalities Test Score (SDMT)
Day 1(n=18, 23)
|
41.2 Number of correct matches
Standard Deviation 9.2
|
40.7 Number of correct matches
Standard Deviation 14.7
|
|
Symbol Digit Modalities Test Score (SDMT)
Day 28 (n=19, 23)
|
42.4 Number of correct matches
Standard Deviation 12.0
|
40.8 Number of correct matches
Standard Deviation 14.7
|
|
Symbol Digit Modalities Test Score (SDMT)
Day 56 (n=15)
|
48.7 Number of correct matches
Standard Deviation 12.3
|
NA Number of correct matches
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 56Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Digit Span Test Score
Forward-Day 1 (n=18, 23)
|
9.5 Number of correct items
Standard Deviation 2.7
|
9.8 Number of correct items
Standard Deviation 2.6
|
|
Digit Span Test Score
Backward-Day 1 (n=18, 23)
|
7.3 Number of correct items
Standard Deviation 2.0
|
6.3 Number of correct items
Standard Deviation 2.4
|
|
Digit Span Test Score
Forward-Day 28 (n=19, 23)
|
10.6 Number of correct items
Standard Deviation 3.0
|
10.4 Number of correct items
Standard Deviation 2.3
|
|
Digit Span Test Score
Backward- Day 28 (n=19, 23)
|
7.0 Number of correct items
Standard Deviation 2.6
|
7.0 Number of correct items
Standard Deviation 2.6
|
|
Digit Span Test Score
Forward-Day 56 (n=15)
|
10.3 Number of correct items
Standard Deviation 2.8
|
NA Number of correct items
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Digit Span Test Score
Backward-Day 56 (n=15)
|
7.4 Number of correct items
Standard Deviation 2.8
|
NA Number of correct items
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
SECONDARY outcome
Timeframe: Day 1, Day 28 and Day 56Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
PWB-Day 1 (n=18, 23)
|
14.1 units on a scale
Standard Deviation 3.3
|
15.3 units on a scale
Standard Deviation 5.1
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
SWB-Day 1 (n=18, 23)
|
20.9 units on a scale
Standard Deviation 6.7
|
19.8 units on a scale
Standard Deviation 5.1
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
EWB-Day 1 (n=18, 23)
|
16.9 units on a scale
Standard Deviation 4.3
|
17.5 units on a scale
Standard Deviation 3.7
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
FWB-Day 1 (n=18, 23)
|
14.8 units on a scale
Standard Deviation 3.6
|
14.6 units on a scale
Standard Deviation 4.2
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Fatigue-Day 1 (n=18, 23)
|
19.2 units on a scale
Standard Deviation 8.7
|
18.8 units on a scale
Standard Deviation 8.9
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
FACIT-G-Day 1 (n=18, 23)
|
67.0 units on a scale
Standard Deviation 11.6
|
68.9 units on a scale
Standard Deviation 11.4
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
TOI-Day 1 (n=18, 23)
|
49.0 units on a scale
Standard Deviation 12.2
|
49.4 units on a scale
Standard Deviation 15.3
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Total-Day 1 (n=19, 23)
|
86.2 units on a scale
Standard Deviation 15.8
|
86.1 units on a scale
Standard Deviation 20.4
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
PWB-Day 28 (n=19, 23)
|
16.5 units on a scale
Standard Deviation 6.6
|
17.4 units on a scale
Standard Deviation 6.3
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
EWB-Day 28 (n=19, 23)
|
16.5 units on a scale
Standard Deviation 5.3
|
18.7 units on a scale
Standard Deviation 4.3
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
SWB-Day 28 (n=19, 23)
|
21.3 units on a scale
Standard Deviation 7.5
|
20.8 units on a scale
Standard Deviation 5.4
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
FWB-Day 28 (n=19, 23)
|
14.4 units on a scale
Standard Deviation 5.1
|
16.8 units on a scale
Standard Deviation 4.5
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Fatigue-Day 28 (n=19, 23)
|
28.0 units on a scale
Standard Deviation 13.22
|
26.5 units on a scale
Standard Deviation 11.7
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
FACIT-G-Day 28 (n=19, 23)
|
68.5 units on a scale
Standard Deviation 20.5
|
75.8 units on a scale
Standard Deviation 12.9
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
TOI-Day 28 (n=19, 23)
|
59.4 units on a scale
Standard Deviation 23.5
|
62.9 units on a scale
Standard Deviation 18.7
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Total-Day 28 (n=19, 23)
|
96.5 units on a scale
Standard Deviation 31.3
|
101.3 units on a scale
Standard Deviation 21.9
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
PWB-Day 56 (n=15)
|
17.8 units on a scale
Standard Deviation 5.1
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
EWB-Day 56 (n=15)
|
22.1 units on a scale
Standard Deviation 5.7
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
SWB-Day 56 (n=15)
|
18.7 units on a scale
Standard Deviation 3.4
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
FWB-Day 56 (n=15)
|
13.5 units on a scale
Standard Deviation 3.8
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Fatigue-Day 56 (n=15)
|
29.7 units on a scale
Standard Deviation 9.2
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
FACIT-G-Day 56 (n=15)
|
73.2 units on a scale
Standard Deviation 12.1
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
TOI-Day 56 (n=15)
|
62.7 units on a scale
Standard Deviation 14.6
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Total-Day 56 (n=15)
|
101.8 units on a scale
Standard Deviation 18.7
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
SECONDARY outcome
Timeframe: Day 1, Day 28 and Day 56Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Score
Anxiety-Day 1 (n=18, 23)
|
13.4 units on a scale
Standard Error 21.4
|
8.3 units on a scale
Standard Error 2.9
|
|
Hospital Anxiety and Depression Scale (HADS) Score
Depression-Day 1 (n=18, 23)
|
7.8 units on a scale
Standard Error 2.7
|
7.6 units on a scale
Standard Error 3.2
|
|
Hospital Anxiety and Depression Scale (HADS) Score
Anxiety-Day 28 (n=19, 23)
|
6.9 units on a scale
Standard Error 4.6
|
5.5 units on a scale
Standard Error 3.3
|
|
Hospital Anxiety and Depression Scale (HADS) Score
Depression-Day 28 (n=19, 23)
|
10.3 units on a scale
Standard Error 17.8
|
6.6 units on a scale
Standard Error 3.6
|
|
Hospital Anxiety and Depression Scale (HADS) Score
Anxiety-Day 56 (n=15)
|
7.0 units on a scale
Standard Error 3.4
|
NA units on a scale
Standard Error NA
Day 56 data was only evaluated for the Armodafinil arm
|
|
Hospital Anxiety and Depression Scale (HADS) Score
Depression-Day 56 (n=15)
|
5.7 units on a scale
Standard Error 2.9
|
NA units on a scale
Standard Error NA
Day 56 data was only evaluated for the Armodafinil arm
|
SECONDARY outcome
Timeframe: Day 1, Day 28 and Day 56Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness
Outcome measures
| Measure |
Armodafinil
n=25 Participants
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.
|
Placebo-First
n=25 Participants
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS) Score
Day 1(n=18, 23)
|
12.2 units on a scale
Standard Deviation 5.1
|
11.5 units on a scale
Standard Deviation 4.5
|
|
Epworth Sleepiness Scale (ESS) Score
Day 28 (n=19, 23)
|
10.1 units on a scale
Standard Deviation 5.1
|
10.0 units on a scale
Standard Deviation 4.6
|
|
Epworth Sleepiness Scale (ESS) Score
Day 56 (n=15)
|
11.5 units on a scale
Standard Deviation 4.5
|
NA units on a scale
Standard Deviation NA
Day 56 data was only evaluated for the Armodafinil arm
|
Adverse Events
Armodafinil
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo-First
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Armodafinil
n=50 participants at risk
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).
|
Placebo-First
n=25 participants at risk
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
AEs presented were those occurring during from Day 1 to Day 28 only
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Eye disorders
Ptosis
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
Other adverse events
| Measure |
Armodafinil
n=50 participants at risk
The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).
|
Placebo-First
n=25 participants at risk
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
AEs presented were those occurring during from Day 1 to Day 28 only
|
|---|---|---|
|
Blood and lymphatic system disorders
G3/G4 Leukopenia
|
4.0%
2/50 • Number of events 2 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
|
Blood and lymphatic system disorders
G3/G4 Lymphopenia
|
6.0%
3/50 • Number of events 3 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
|
Blood and lymphatic system disorders
G3/G4 Neutropenia
|
4.0%
2/50 • Number of events 2 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Renal and urinary disorders
G3/G4 BUN (increased)
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Renal and urinary disorders
G3/G4 Creatinine (increased)
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
General disorders
G4 Edema
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Blood and lymphatic system disorders
G3/G4 Eosinophils (increased)
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Metabolism and nutrition disorders
G3/G4 Hypokalemia
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Ear and labyrinth disorders
G3/G4 Infection (ear)
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
G3/G4 Neuroma
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
|
Infections and infestations
G3/G4 Upper Respiratory Infection
|
2.0%
1/50 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place