Evaluate Weight Gain Using 2 Different Formulations of Me... | NCT00637572

Name	Class
Quintiles, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Megestrol acetate oral suspension nanocrystal dispersion	Experimental	Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL	Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Megestrol acetate oral suspension micronized formulation	Active Comparator	Megestrol acetate oral suspension micronized formulation 60 mg/mL	Drug: Megestrol acetate oral suspension 40 mg/mL

Name	Type	Description	Arm Group Labels	Other Names
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL	Drug	Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)

Measure	Description	Time Frame
Change in Body Weight	Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment	Baseline (Day 1) to Week 12

Measure	Description	Time Frame
Change From Baseline in Lean Mass		Baseline (Day 1) to Week 12
Change From Baseline in Impedance	Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of and willing to provide informed consent
Evidence of HIV infection (either HIV-seropositive, CD4+ T-cell count of ≤350/mm3 or other clinically accepted indicator)
An unintentional weight loss resulting in a weight 10% less than the lower limit of Ideal Body Weight for frame size, or a recent history of unintentional weight loss of 10% from the subjects baseline
Weight losses was clinically associated with AIDS-related wasting and not related to any other disease process
Women of childbearing potential had to agree to use effective contraception for the duration of the study and for two weeks after the last dose
Clinical laboratory values had to be within normal limits or out-of-range limits must be designated as not clinically significant (some exceptions per protocol)
Able to read and write in the study related documents translated into the primary local language
Capable of and willing to return to the clinic regularly for study visits
Must have been taking a stable regimen of accepted HIV anti-retroviral treatments for at least two weeks prior to study entry
Capable of completing a 3-day food intake diary with instruction
Willing to abstain from any illegal or recreational drug substances for the duration of the trial
Willing to abstain from taking any other medications or substances known to affect appetite or weight gain (eg, steroids [other than those inhaled for treatment of asthmatic conditions], nutritional supplements [other than vitamins or minerals], dronabinol, recombinant human growth hormone, etc.)

Exclusion Criteria:

Weight loss due to factors other than AIDS-related wasting
Enrollment in any other clinical trial
Lack of access to regular meals
Women of childbearing potential could not be pregnant or nursing
Clinically severe depression evidenced by a baseline score of 17 or more on the Hamilton Depression Rating Scale (GRID-HAMD-17)
Recent evidence of or history of significant psychiatric illness that may have compromised the subject's ability to comply with the study requirements
Intractable or frequent vomiting that regularly interfered with eating
Clinically significant diarrhea that would have interfered with absorption of foods or medications
Clinically significant oral lesions or dental conditions that would have interfered with eating a regular diet
History or evidence of thromboembolic events or any first degree relative with a history of thromboembolic events
Active AIDS-defining illness or other clinically significant or uncontrolled medical problems
Current evidence of or history of diabetes mellitus or hypoadrenalism
Systemic treatment with glucocorticoids within the 12 months prior to study entry

Name	Affiliation	Role
Jan Fourie, MD	58 Ann Street, Dundee, KZ-Natal 3000, S. Africa	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Drexel University College of Medicine		Philadelphia	Pennsylvania	19102	United States
Victoria Hospital

PubMed Identifier	Type	Citation	Retractions
	Result	Wanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216

Label	URL
Link to published study	View source

ID	Title	Description
FG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
FG001	Megestrol Acetate Oral Suspension Micronized Formulation

ID	Title	Description
BG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per as single-dose for 12 weeks
BG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per as single-dose for 12 weeks
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00032 BG00131 BG00263

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Body Weight

Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG00032 OG00131

Title

Denominators

Categories

Overall

Title	Measurements
	OG0005.4± 5.32 OG0013.5± 4.03

Male

Title	Measurements
	OG000

Secondary

Change From Baseline in Lean Mass

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Impedance

Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.

Posted

Mean

Standard Deviation

ohms

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Body Fat Mass

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change in Hip Circumference

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change in Waist Circumference

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change in Tricep Skinfold

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change in Mid-arm Circumference

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit

Posted

Mean

Standard Deviation

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change in Total Energy

Food intake was quantified by the 24-hour recall food diary

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.

Posted

Mean

Standard Deviation

kcal

Baseline (Day 1) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants	OG000

Secondary

Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)

The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.

Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.

Posted

Mean

Standard Deviation

Baseline (Day 3) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Secondary

Appetite at Baseline (Day 3) and Week 12

Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was "To what extent has your appetite changed since the start of treatment?" The response was captured on a VAS scale in cm with a range from 0 ( "much worse") to 10 ("much better").

Posted

Mean

Standard Deviation

Baseline (Day 3) to Week 12

ID	Title	Description
OG000	Megestrol Acetate Oral Suspension Nanocrystal Dispersion	Subjects were treated with 575 mg per day as single-dose for 12 weeks
OG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single-dose for 12 weeks

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected31 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected31 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 events3 affected32 at risk EG0014 events4 affected31 at risk
Adrenal suppression	Endocrine disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 events2 affected32 at risk EG0012 events2 affected31 at risk
Asthenia	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Death of unknown cause	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Oedema peripheral	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Adrenal gland tuberculosis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected31 at risk
Gastroenteritis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
HIV infection	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Meningitis tuberculous	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected31 at risk
Pneumonia	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected31 at risk
Blood cortisol abnormal	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0006 events6 affected32 at risk EG0013 events3 affected31 at risk
Blood cortisol decreased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected31 at risk
Venous pressure jugular increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Cerebral infarction	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected31 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected31 at risk
Hypertension	Vascular disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 events1 affected32 at risk EG0010 events0 affected31 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0010 affected31 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 affected32 at risk EG0012 affected31 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0012 affected31 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 8.0	Non-systematic Assessment	EG0004 affected32 at risk EG0018 affected31 at risk
Adrenal suppression	Endocrine disorders	MedDRA 8.0	Non-systematic Assessment	EG0004 affected32 at risk EG0012 affected31 at risk
Cushingoid	Endocrine disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0012 affected31 at risk
Constipation	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0011 affected31 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0014 affected31 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0006 affected32 at risk EG0012 affected31 at risk
Flatulence	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0010 affected31 at risk
Gastritis	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Nausea	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0013 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 affected32 at risk EG0014 affected31 at risk
Asthenia	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0005 affected32 at risk EG0010 affected31 at risk
Non-cardiac chest pain	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0013 affected31 at risk
Oedema peripheral	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0013 affected31 at risk
Pyrexia	General disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0014 affected31 at risk
Bronchitis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0011 affected31 at risk
Gastroenteritis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0013 affected31 at risk
Nasopharyngitis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0011 affected31 at risk
Pharyngitis	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0000 affected32 at risk EG0014 affected31 at risk
Urinary tract infection	Infections and infestations	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0011 affected31 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Alanine aminotransferase increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0012 affected31 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Blood cholesterol increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0011 affected31 at risk
Blood cortisol abnormal	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0004 affected32 at risk EG0012 affected31 at risk
Blood cortisol decreased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0014 affected31 at risk
Blood glucose increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG00012 affected32 at risk EG0015 affected31 at risk
Blood triglycerides increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0011 affected31 at risk
Cardiac murmur	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0011 affected31 at risk
Low density lipoprotein increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0010 affected31 at risk
Mean cell haemoglobin increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0005 affected32 at risk EG0015 affected31 at risk
Mean cell volume increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0008 affected32 at risk EG0015 affected31 at risk
Red blood cell count decreased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0005 affected32 at risk EG0012 affected31 at risk
Red cell distribution width increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0009 affected32 at risk EG0015 affected31 at risk
Venous pressure jugular increased	Investigations	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0014 affected31 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0012 affected31 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0011 affected31 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0013 affected31 at risk
Dizziness	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Headache	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0008 affected32 at risk EG0016 affected31 at risk
Paraesthesia	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 affected32 at risk EG0012 affected31 at risk
Somnolence	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Tremor	Nervous system disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Insomnia	Psychiatric disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0011 affected31 at risk
Libido decreased	Psychiatric disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0011 affected31 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0012 affected31 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 8.0	Non-systematic Assessment	EG0001 affected32 at risk EG0012 affected31 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0009 affected32 at risk EG0016 affected31 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0004 affected32 at risk EG0013 affected31 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Non-systematic Assessment	EG0000 affected32 at risk EG0012 affected31 at risk
Periorbital oedema	Skin and subcutaneous tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 8.0	Non-systematic Assessment	EG0003 affected32 at risk EG0012 affected31 at risk
Flushing	Vascular disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0010 affected31 at risk
Hypertension	Vascular disorders	MedDRA 8.0	Non-systematic Assessment	EG0005 affected32 at risk EG0015 affected31 at risk
Systolic hypertension	Vascular disorders	MedDRA 8.0	Non-systematic Assessment	EG0002 affected32 at risk EG0011 affected31 at risk

ID	Term
D015658	HIV Infections
D002100	Cachexia
D000855	Anorexia
D019247	HIV Wasting Syndrome
D015431	Weight Loss
D001836	Body Weight Changes
D004614	Emaciation

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D013851	Thinness
D012817	Signs and Symptoms, Digestive
D019282	Wasting Syndrome
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D009748	Nutrition Disorders

ID	Term
D008535	Megestrol
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Megestrol Acetate Oral Suspension NanoCrystal Dispersion	Subjects were treated with 575 mg per day as single dose for 12 weeks			14	32	30	32
EG001	Megestrol Acetate Oral Suspension Micronized Formulation	Subjects were treated with 800 mg per day as single dose for 12 weeks			14	31	30	31