Trial Outcomes & Findings for Efficacy and Safety of Sirolimus in LAM (NCT NCT00414648)
NCT ID: NCT00414648
Last Updated: 2023-11-02
Results Overview
FEV1 values reported are in liters or milliliters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. Normative ranges are determined in populations stratified by gender, height, age and race/ethnicity. Higher FEV1 values indicate better lung function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2023-11-02
Participant Flow
Recruitment began in December, 2006 and ended in August 2009. Recruitment occurred at the hospital based study sites.
Participant milestones
| Measure |
Sirolimus Treatment Arm
Participants will receive sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
Placebo Treatment Arm
Participants will receive placebo sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily placebo sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
43
|
|
Overall Study
COMPLETED
|
41
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
| Measure |
Sirolimus Treatment Arm
Participants will receive sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
Placebo Treatment Arm
Participants will receive placebo sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily placebo sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Sirolimus in LAM
Baseline characteristics by cohort
| Measure |
Sirolimus Treatment Arm
n=46 Participants
Participants will receive sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
Placebo Treatment Arm
n=43 Participants
Participants will receive placebo sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily placebo sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Intention to treat
FEV1 values reported are in liters or milliliters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. Normative ranges are determined in populations stratified by gender, height, age and race/ethnicity. Higher FEV1 values indicate better lung function.
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Changes in Forced Expiratory Volume in One-second (FEV1) Slope in Milliliters Per Month
|
1 milliliters per month
Standard Deviation 2
|
-12 milliliters per month
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intention to treat
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Percent of Participants With Serious Adverse Events
|
50 percentage of participants with SAE
|
41.86 percentage of participants with SAE
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intention To Treat
FVC values are reported in liters or milliliters. Normative ranges are determined in populations that are stratified by gender, height, age and race/ethnicity. There are no minimum or maximum values as it is a physiologic measure of lung function and varies from individual to individual. Higher FVC scores indicate better lung function.
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Changes in FVC Slope in ml/Month
|
8 milliliters/month
Standard Deviation 3
|
-11 milliliters/month
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intention to treat
Diffusing capacity for carbon monoxide is abbreviated DLCO. DLCO is measured in liters and milliliters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. A lower DLCO means that there is lower lung function.
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Rate of Change in Diffusing Capacity for Carbon Monoxide (DLCO) in ml/Min/mmHg
|
-0.01 ml/min/mmHg
Standard Deviation 0.02
|
-0.06 ml/min/mmHg
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intention to treat
There are two methods for measurement of total lung volume, nitrogen or helium wash out (total lung capacity or TLC), or plethysmography (Total gas volume or TGV). TLC or TGV is measured in milliliters or liters. Normative ranges for TLC or TGV are stratified by age, height, and sex in population based studies of normal subjects.. There are no definite minimum and maximum values of lung volume as it is a physiological measure of lung function and varies from individual to individual. A low TGV or TLC is suggestive of a restrictive lung disease, and a high TGV or TLC is consistent with obstructive lung disease with hyperinflation.
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Rate of Change in Total Lung Volume in ml Per Month
|
8 milliliters/month
Standard Deviation 7
|
-2 milliliters/month
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intention to treat
Number of meters walked in six minutes. There is no minimum or maximum number of feet walked as this varies from individual to individual. A higher number of feet walked indicates better exercise tolerance
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Rate of Change in Six Minute Walk Distance in Meters/Month
|
1.65 meters/month
Standard Deviation 0.81
|
1.47 meters/month
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline to Month 12Serum VEGF-D is a protein produced by LAM cells that serves as a biomarker of mTOR activation and sirolimus response. Mean serum levels of VEGF-D in normal subjects are around 350 pg/ml. Higher levels of serum VEGF-D are correlated with greater degrees of mTOR activation, and a fall in VEGF-D levels suggest suppression of the mTOR axis.
Outcome measures
| Measure |
Sirolimus
n=46 Participants
sirolimus treatment arm FEV1 at 12 months.
|
Placebo
n=43 Participants
Placebo arm FEV1 at 12 months
|
|---|---|---|
|
Rate of Change in Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels in pg/ml Per Month
|
-88.01 pg/ml per month
Standard Deviation 16.61
|
-2.42 pg/ml per month
Standard Deviation 17.23
|
Adverse Events
Sirolimus Treatment Arm
Serious events: 23 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo Treatment Arm
Serious events: 18 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sirolimus Treatment Arm
n=46 participants at risk
Participants will receive sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
Placebo Treatment Arm
n=43 participants at risk
Participants will receive placebo sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily placebo sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
|---|---|---|
|
Cardiac disorders
Cardiac
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Blood and lymphatic system disorders
blood or bone marrow
|
10.9%
5/46 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Infection
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Metabolic
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Pain
|
15.2%
7/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
30.2%
13/43 • Number of events 13 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Vascular disorders
Vascular
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
Other adverse events
| Measure |
Sirolimus Treatment Arm
n=46 participants at risk
Participants will receive sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
Placebo Treatment Arm
n=43 participants at risk
Participants will receive placebo sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily placebo sirolimus in 2010. Second year of follow up eliminated after August 31, 2010.
|
|---|---|---|
|
Blood and lymphatic system disorders
"Blood and lymphatic system disorders - Other, specify"
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Cardiac disorders
"Cardiac disorders - Other, specify"
|
8.7%
4/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Cardiac disorders
Pericardial effusion
|
6.5%
3/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.3%
2/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Ear and labyrinth disorders
"Ear and labyrinth disorders - Other, specify"
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Endocrine disorders
"Endocrine disorders - Other, specify"
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Eye disorders
Dry eye
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Eye disorders
Conjunctivitis
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Eye disorders
"Eye disorders - Other, specify"
|
10.9%
5/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Eye disorders
Flashing lights
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Cheilitis
|
2.2%
1/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Constipation
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Periodontal disease
|
2.2%
1/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Dental caries
|
4.3%
2/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Diarrhea
|
63.0%
29/46 • Number of events 80 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
32.6%
14/43 • Number of events 54 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
2/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
"Gastrointestinal disorders - Other, specify"
|
28.3%
13/46 • Number of events 19 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
30.2%
13/43 • Number of events 17 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.9%
5/46 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 16 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.5%
3/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Mucositis oral
|
54.3%
25/46 • Number of events 67 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
51.2%
22/43 • Number of events 48 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Nausea
|
39.1%
18/46 • Number of events 31 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
25.6%
11/43 • Number of events 17 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
6/46 • Number of events 9 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
5/46 • Number of events 8 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
"General disorders and administration site conditions - Other, specify"
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Sudden death NOS
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Edema face
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Edema limbs
|
23.9%
11/46 • Number of events 13 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
16.3%
7/43 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Fatigue
|
30.4%
14/46 • Number of events 21 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
30.2%
13/43 • Number of events 20 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Fever
|
13.0%
6/46 • Number of events 8 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Pain
|
52.2%
24/46 • Number of events 63 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
46.5%
20/43 • Number of events 48 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Non-cardiac chest pain
|
21.7%
10/46 • Number of events 12 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
16.3%
7/43 • Number of events 12 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
General disorders
Chills
|
8.7%
4/46 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Hepatobiliary disorders
"Hepatobiliary disorders - Other, specify"
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Immune system disorders
"Immune system disorders - Other, specify"
|
8.7%
4/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Enterocolitis infectious
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
"Infections and infestations - Other, specify"
|
69.6%
32/46 • Number of events 98 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
55.8%
24/43 • Number of events 79 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Lung infection
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Gum infection
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Injury, poisoning and procedural complications
Bruising
|
10.9%
5/46 • Number of events 10 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Injury, poisoning and procedural complications
Burn
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
6/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Cholesterol high
|
19.6%
9/46 • Number of events 11 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
14.0%
6/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Creatinine increased
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Forced expiratory volume decreased
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
White blood cell decreased
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Lymphocyte count decreased
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
"Investigations - Other, specify"
|
28.3%
13/46 • Number of events 20 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Weight gain
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Investigations
Weight loss
|
10.9%
5/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Acidosis
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
2/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.3%
2/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
"Musculoskeletal and connective tissue disorder - Other, specify"
|
39.1%
18/46 • Number of events 28 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
27.9%
12/43 • Number of events 19 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
1/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
3/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Dizziness
|
19.6%
9/46 • Number of events 21 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
20.9%
9/43 • Number of events 13 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Memory impairment
|
2.2%
1/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
"Nervous system disorders - Other, specify"
|
10.9%
5/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Headache
|
28.3%
13/46 • Number of events 33 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
27.9%
12/43 • Number of events 27 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Neuralgia
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Sinus pain
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Seizure
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Dysgeusia
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Nervous system disorders
Tremor
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Psychiatric disorders
Insomnia
|
15.2%
7/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Psychiatric disorders
Agitation
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Psychiatric disorders
Anxiety
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Psychiatric disorders
Depression
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Renal and urinary disorders
Cystitis noninfective
|
4.3%
2/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Renal and urinary disorders
Proteinuria
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Renal and urinary disorders
"Renal and urinary disorders - Other, specify"
|
10.9%
5/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Renal and urinary disorders
Urinary frequency
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Uterine pain
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
"Reproductive system and breast disorders - Other, specify"
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.9%
5/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 9 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.1%
18/46 • Number of events 28 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
37.2%
16/43 • Number of events 25 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.1%
12/46 • Number of events 18 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
39.5%
17/43 • Number of events 34 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
4/46 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.9%
5/46 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
8.7%
4/46 • Number of events 7 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.7%
4/46 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
9.3%
4/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.9%
5/46 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
14.0%
6/43 • Number of events 11 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
7.0%
3/43 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
"Respiratory, thoracic and mediastinal disorders - Other, specify"
|
58.7%
27/46 • Number of events 55 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
60.5%
26/43 • Number of events 49 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
"Skin and subcutaneous tissue disorders - Other, specify"
|
41.3%
19/46 • Number of events 30 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
18.6%
8/43 • Number of events 15 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
2/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.0%
6/46 • Number of events 11 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
16.3%
7/43 • Number of events 8 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
43.5%
20/46 • Number of events 50 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 6 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Vascular disorders
"Vascular disorders - Other, specify"
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Vascular disorders
Hot flashes
|
0.00%
0/46 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Vascular disorders
Hypertension
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
11.6%
5/43 • Number of events 5 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
0.00%
0/43 • Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
|
Additional Information
Francis X. McCormack, MD
Division of Pulmonary, Critical Care and Sleep Medicine, University of Cincinnati
Phone: 513-558-4831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place