Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)

• Sponsor: Helsinn Therapeutics (U.S.), Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01387282
• Collaborator: (none)
• Enrollment: 495
• Locations: 47
• Arms: 2
• Duration (Months): 43.1
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Condition or Disease	Intervention/Treatment	Phase
Cachexia; Non-Small Cell Lung Cancer	Drug: Anamorelin HCl; Drug: Placebo	Phase 3

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function.

Study Design

• Study Type: Interventional
• Actual Enrollment: 495 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 100 mg QD Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Drug: Anamorelin HCl; Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal
Placebo Comparator: Placebo Placebo tablets identical in appearance to active tablets; oral administration once daily	Drug: Placebo; Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Outcome Measures

Primary Outcome Measures

1. Change in Lean Body Mass [Change in Lean Body Mass from Baseline Over 12 Weeks]

   Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

2. Change in Handgrip Strength [Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks]

   Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

Secondary Outcome Measures

1. Change in A/CS Domain Score [Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks]

   The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).

2. Change in FACIT-F Fatigue Domain Score [Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks]

   The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).

3. Change in Body Weight [Change in Body Weight from Baseline Over 12 Weeks]

   Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented diagnosis of unresectable Stage III or Stage IV NSCLC

• Patients may be receiving maintenance chemotherapy

• Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization

• Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization

• Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2

• Body mass index ≤30 kg/m2

• Life expectancy of >4 months at time of screening

• ECOG performance status ≤2

• Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal

• Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute

• Ability to understand and comply with the procedures for the HGS evaluation

• If a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)

• Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures

Exclusion Criteria:

• Other forms of lung cancer (e.g., small cell, mesothelioma)

• Women who are pregnant or breast-feeding

• Known HIV, hepatitis (B&C), or active tuberculosis

• Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period

• Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol

• Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded

• Has an active, uncontrolled infection

• Has uncontrolled diabetes mellitus

• Has untreated clinically relevant hypothyroidism

• Has known or symptomatic brain metastases

• Receiving strong CYP3A4 inhibitors within 14 days of randomization

• Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration

• Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation

• Has had previous exposure to Anamorelin HCl

• Patients actively receiving a concurrent investigational agent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Corona	California	United States
2		Fountain Valley	California	United States
3		Glendale	California	United States
4		Washington, D.C.	District of Columbia	United States
5		Baltimore	Maryland	United States
6		Detroit	Michigan	United States
7		Lake Success	New York	United States
8		Durham	North Carolina	United States
9		Cincinnati	Ohio	United States
10		Cleveland	Ohio	United States
11		Sylvania	Ohio	United States
12		West Reading	Pennsylvania	United States
13		Charleston	South Carolina	United States
14		Falls Church	Virginia	United States
15		Prairiewood	New South Wales	Australia
16		East Bentleigh	Victoria	Australia
17		Parkville	Victoria	Australia
18		Adelaide		Australia
19		Budapest		Hungary
20		Nyiregyhaza		Hungary
21		Szekesfehervar		Hungary
22		Szikszo		Hungary
23		Torokbalint		Hungary
24		Beer-Sheva		Israel
25		Haifa		Israel
26		Jerusalem		Israel
27		Kfar Saba		Israel
28		Petach Tikvah		Israel
29		Tel Aviv		Israel
30		Tel-Hashomer		Israel
31		Zerifin		Israel
32		Bydgoszcz		Poland
33		Grudziadz		Poland
34		Katowice		Poland
35		Krakow		Poland
36		Lodz		Poland
37		Lublin		Poland
38		Szczecin		Poland
39		Warszawa		Poland
40		Ekaterinburg		Russian Federation
41		Krasnodar		Russian Federation
42		Moscow		Russian Federation
43		Novosibirsk		Russian Federation
44		Saint Petersburg		Russian Federation
45		St. Petersburg		Russian Federation
46		Leicester		United Kingdom
47		Middlesex		United Kingdom

Sponsors and Collaborators

• Helsinn Therapeutics (U.S.), Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helsinn Therapeutics (U.S.), Inc
• ClinicalTrials.gov Identifier: NCT01387282
• Other Study ID Numbers: HT-ANAM-302
• First Posted: Jul 4, 2011
• Last Update Posted: Oct 27, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Wasting Syndrome; Cachexia

Study Results

Participant Flow

Recruitment Details	Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index [BMI] < 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.
Pre-assignment Detail	Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Period Title: Overall Study
STARTED	330	165
ITT Population	330	165
MITT Population	268	136
Safety Population	330	161
COMPLETED	233	118
NOT COMPLETED	97	47

Baseline Characteristics

Arm/Group Title	Anamorelin HCl	Placebo	Total
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Total of all reporting groups
Overall Participants	330	165	495
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	209 63.3%	108 65.5%	317 64%
>=65 years	121 36.7%	57 34.5%	178 36%
Sex: Female, Male (Count of Participants)
Female	90 27.3%	43 26.1%	133 26.9%
Male	240 72.7%	122 73.9%	362 73.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 0.6%	1 0.2%
Native Hawaiian or Other Pacific Islander	1 0.3%	0 0%	1 0.2%
Black or African American	2 0.6%	1 0.6%	3 0.6%
White	326 98.8%	162 98.2%	488 98.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.3%	1 0.6%	2 0.4%
Region of Enrollment (participants) [Number]
Poland	133 40.3%	70 42.4%	203 41%
United Kingdom	1 0.3%	0 0%	1 0.2%
Hungary	72 21.8%	36 21.8%	108 21.8%
Australia	14 4.2%	8 4.8%	22 4.4%
Israel	8 2.4%	5 3%	13 2.6%
Russian Federation	92 27.9%	41 24.8%	133 26.9%
United States	10 3%	5 3%	15 3%
Geographic region (Count of Participants)
North America	10 3%	5 3%	15 3%
West Europe	142 43%	75 45.5%	217 43.8%
East Europe + Russia	164 49.7%	77 46.7%	241 48.7%
Australia	14 4.2%	8 4.8%	22 4.4%

Outcome Measures

1. Primary Outcome

Title	Change in Lean Body Mass
Description	Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Time Frame	Change in Lean Body Mass from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Measure Participants	321	157
Median (95% Confidence Interval) [kg]	0.65	-0.98

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Wilcoxon rank sum test
	Comments

2. Primary Outcome

Title	Change in Handgrip Strength
Description	Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
Time Frame	Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Measure Participants	321	157
Median (95% Confidence Interval) [kg]	-1.49	-0.95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6480
	Comments
	Method	Wilcoxon rank sum test
	Comments

3. Secondary Outcome

Title	Change in A/CS Domain Score
Description	The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).
Time Frame	Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Measure Participants	268	136
Least Squares Mean (Standard Error) [scores on a scale]	3.48 (0.944)	1.34 (1.032)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Change in FACIT-F Fatigue Domain Score
Description	The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).
Time Frame	Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Measure Participants	268	136
Least Squares Mean (Standard Error) [scores on a scale]	1.37 (1.169)	1.23 (1.293)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8637
	Comments
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Change in Body Weight
Description	Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
Time Frame	Change in Body Weight from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.	Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Measure Participants	268	136
Least Squares Mean (Standard Error) [kg]	0.95 (0.386)	-0.57 (0.438)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.
Adverse Event Reporting Description	Adverse events that occurred following the signature of the informed consent, but prior to the first dose of study drug were not reported as adverse events in this trial. The adverse event reporting period also ended if the patient began an alternative therapy within 28 days of the last administration of study drug. The Safety Population, defined as all randomized patients who received any study drug, was used for all safety analyses.
Arm/Group Title	Anamorelin HCl		Placebo
Arm/Group Description	Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.		Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
All Cause Mortality
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/330 (22.1%)		27/161 (16.8%)
Blood and lymphatic system disorders
Anaemia	3/330 (0.9%)	3	3/161 (1.9%)	3
Neutropenia	2/330 (0.6%)	2	1/161 (0.6%)	1
Febrile neutropenia	2/330 (0.6%)	2	2/161 (1.2%)	2
Pancytopenia	2/330 (0.6%)	2	0/161 (0%)	0
Thrombocytopenia	1/330 (0.3%)	1	0/161 (0%)	0
Agranulocytosis	1/330 (0.3%)	1	0/161 (0%)	0
Pulmonary haemorrhage	5/330 (1.5%)	5	0/161 (0%)	0
Cardiac disorders
Atrial fibrillation	1/330 (0.3%)	1	1/161 (0.6%)	1
Atrial tachycardia	1/330 (0.3%)	1	0/161 (0%)	0
Tachycardia paroxysmal	1/330 (0.3%)	1	0/161 (0%)	0
cardiopulmonary failure	1/330 (0.3%)	1	0/161 (0%)	0
Cardiac failure congestive	1/330 (0.3%)	1	0/161 (0%)	0
Gastrointestinal disorders
Nausea	1/330 (0.3%)	1	0/161 (0%)	0
Vomiting	2/330 (0.6%)	2	0/161 (0%)	0
Abdominal pain	0/330 (0%)	0	1/161 (0.6%)	1
General disorders
Death	3/330 (0.9%)	3	0/161 (0%)	0
Pyrexia	3/330 (0.9%)	3	0/161 (0%)	0
General physical health deterioration	1/330 (0.3%)	1	0/161 (0%)	0
Infections and infestations
Pneumonia	6/330 (1.8%)	6	0/161 (0%)	0
Sepsis	0/330 (0%)	0	1/161 (0.6%)	1
Tuberculosis	0/330 (0%)	0	1/161 (0.6%)	1
Viral infection	0/330 (0%)	0	1/161 (0.6%)	1
Bronchitis	0/330 (0%)	0	1/161 (0.6%)	1
Infective exacerbation of chronic obstructive airways disease	0/330 (0%)	0	1/161 (0.6%)	1
Gastroenteritis	1/330 (0.3%)	1	0/161 (0%)	0
Injury, poisoning and procedural complications
Head injury	1/330 (0.3%)	1	0/161 (0%)	0
Fall	1/330 (0.3%)	1	0/161 (0%)	0
Investigations
Blood creatine increased	1/330 (0.3%)	1	0/161 (0%)	0
Blood glucose increased	1/330 (0.3%)	1	0/161 (0%)	0
Metabolism and nutrition disorders
Hyperglycaemia	1/330 (0.3%)	1	0/161 (0%)	0
Dehydration	1/330 (0.3%)	1	1/161 (0.6%)	1
Electrolyte imbalance	1/330 (0.3%)	1	0/161 (0%)	0
Diabetes mellitus	1/330 (0.3%)	1	0/161 (0%)	0
Diabetes mellitus inadequate control	1/330 (0.3%)	1	0/161 (0%)	0
Hypokalaemia	1/330 (0.3%)	1	0/161 (0%)	0
Hyperkalaemia	1/330 (0.3%)	1	0/161 (0%)	0
Hypertriglyceridaemia	1/330 (0.3%)	1	0/161 (0%)	0
Hypercalcaemia	1/330 (0.3%)	1	0/161 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression	25/330 (7.6%)	25	10/161 (6.2%)	10
Gastric cancer	1/330 (0.3%)	1	0/161 (0%)	0
Epiglottic carcinoma	1/330 (0.3%)	1	0/161 (0%)	0
Nervous system disorders
Convulsion	1/330 (0.3%)	1	1/161 (0.6%)	1
cerebrovasculary insufficiency	1/330 (0.3%)	1	0/161 (0%)	0
Cerebrovascular accident	1/330 (0.3%)	1	0/161 (0%)	0
Psychiatric disorders
Completed suicide	1/330 (0.3%)	1	0/161 (0%)	0
Confusional state	1/330 (0.3%)	1	0/161 (0%)	0
Renal and urinary disorders
Haematuria	0/330 (0%)	0	1/161 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/330 (0.3%)	1	1/161 (0.6%)	1
Pulmonary embolism	4/330 (1.2%)	4	0/161 (0%)	0
Pneumothorax	0/330 (0%)	0	1/161 (0.6%)	1
Haemoptysis	1/330 (0.3%)	1	0/161 (0%)	0
Lower respiratory tract infection	2/330 (0.6%)	2	0/161 (0%)	0
Vascular disorders
Circulatory collapse	0/330 (0%)	0	1/161 (0.6%)	1
Hypotension	0/330 (0%)	0	1/161 (0.6%)	1
Extremity necrosis	1/330 (0.3%)	1	0/161 (0%)	0
Peripheral arterial occlusive disease	1/330 (0.3%)	1	0/161 (0%)	0
Other (Not Including Serious) Adverse Events
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	156/330 (47.3%)		72/161 (44.7%)
Blood and lymphatic system disorders
Anaemia	48/330 (14.5%)	61	21/161 (13%)	28
Leukopenia	25/330 (7.6%)	29	6/161 (3.7%)	7
Neutropenia	31/330 (9.4%)	48	10/161 (6.2%)	14
Gastrointestinal disorders
Nausea	19/330 (5.8%)	20	13/161 (8.1%)	13
Vomiting	9/330 (2.7%)	11	9/161 (5.6%)	12
General disorders
Asthenia	29/330 (8.8%)	30	16/161 (9.9%)	19
Metabolism and nutrition disorders
Hyperglycaemia	23/330 (7%)	32	3/161 (1.9%)	3
Skin and subcutaneous tissue disorders
Alopecia	29/330 (8.8%)	35	14/161 (8.7%)	15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor intends to publish the complete study results in a timely manner that is appropriate to the project. Separate publication of a portion of the study results by any PI is discouraged.