BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00395135
• Collaborator: (none)
• Enrollment: 3,182
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 117.7

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Lorcaserin 10 mg BID; Drug: Matching Placebo BID	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 3182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management; A 104-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorcaserin 10 mg BID Lorcaserin 10 mg tablet each morning and evening	Drug: Lorcaserin 10 mg BID; Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.; Other Names: APD356
Placebo Comparator: Matching Placebo BID Matching placebo tablet each morning and evening	Drug: Matching Placebo BID; Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.

Outcome Measures

Primary Outcome Measures

1. Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [52 weeks]

   The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.

2. Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 [104 weeks]

   The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.

Secondary Outcome Measures

1. Year 1: Percent Change in Body Weight From Baseline to Week 52 [52 weeks]

   Year 1: The % change in body weight (kg) from baseline to week 52.

2. Year 2: Percent Change in Body Weight From Week 52 to Week 104 [52 weeks]

   Year 2: The % change in body weight (kg) from week 52 to week 104.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea)

• Ability to complete a 2 year study

Exclusion Criteria:

• Diabetes

• Pregnancy

• History of heart valve disease

• Serious or unstable current or past medical conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arena Pharmaceuticals, Inc.	San Diego	California	United States	92121

Sponsors and Collaborators

• Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Arena Pharmaceuticals, Inc. Home Page

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00395135
• Other Study ID Numbers: APD356-009
• First Posted: Nov 2, 2006
• Last Update Posted: Oct 2, 2019
• Last Verified: Jan 1, 2013

• Keywords provided by Eisai Inc.: Obesity; Weight loss; lorcaserin; APD356; BLOOM; Hypertension; Dyslipidemia; Sleep apnea; glucose tolerance; cardiovascular disease; Arena
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

Participant Flow

Arm/Group Title	Year 1 - Lorcaserin 10 mg BID	Year 1 - Matching Placebo BID	Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)	Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)	Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
Arm/Group Description	lorcaserin 10 mg BID tablets	matching placebo tablets	Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.	Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.	Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
Period Title: Year 1
STARTED	1595	1587	0	0	0
COMPLETED	883	716	0	0	0
NOT COMPLETED	712	871	0	0	0
Period Title: Year 1
STARTED	0	0	573	283	697
COMPLETED	0	0	426	195	507
NOT COMPLETED	0	0	147	88	190

Baseline Characteristics

Arm/Group Title	Year 1 - Lorcaserin 10 mg BID	Year 1 - Matching Placebo BID	Total
Arm/Group Description	lorcaserin 10 mg BID tablets	matching placebo tablets	Total of all reporting groups
Overall Participants	1593	1584	3177
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.8 (11.32)	44.4 (11.11)	44.1 (11.22)
Sex: Female, Male (Count of Participants)
Female	1321 82.9%	1331 84%	2652 83.5%
Male	272 17.1%	253 16%	525 16.5%

Outcome Measures

1. Primary Outcome

Title	Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
Description	The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

MITT with LOCF

Arm/Group Title	Lorcaserin 10 mg BID	Matching Placebo BID
Arm/Group Description	lorcaserin 10 mg BID tablets	matching placebo tablets
Measure Participants	1538	1499
Number [percentage of participants]	47.5 3%	20.3 1.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lorcaserin 10 mg BID, Matching Placebo BID
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 3.0 to 4.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
Description	The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.
Time Frame	104 weeks

Outcome Measure Data

Analysis Population Description

MITT with LOCF

Arm/Group Title	Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)	Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)
Arm/Group Description	Patients were randomized to lorcaserin in Year 1, completed year 1 study with a "Responder" status and randomized to lorcaserin in Year 2.	Patients were randomized to lorcaserin in Year 1, completed year 1 with a "Responder" status and randomized to placebo in Year 2.
Measure Participants	380	175
Number [percentage of participants]	67.9 4.3%	50.3 3.2%

3. Secondary Outcome

Title	Year 1: Percent Change in Body Weight From Baseline to Week 52
Description	Year 1: The % change in body weight (kg) from baseline to week 52.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

MITT with LOCF

Arm/Group Title	Lorcaserin 10 mg BID	Matching Placebo BID
Arm/Group Description	lorcaserin 10 mg BID tablets	matching placebo tablets
Measure Participants	1538	1499
Least Squares Mean (Standard Error) [% change from baseline: body wt (kg)]	-5.87 (0.18)	-2.20 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lorcaserin 10 mg BID, Matching Placebo BID
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion (%)
	Estimated Value	-3.67
	Confidence Interval	(2-Sided) 95%; -4.09 to -3.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Year 2: Percent Change in Body Weight From Week 52 to Week 104
Description	Year 2: The % change in body weight (kg) from week 52 to week 104.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

MITT with LOCF

Arm/Group Title	Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)	Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)	Placebo (Yr 1) / Placebo (Yr 2)
Arm/Group Description	Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.	Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.	Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
Measure Participants	553	267	665
Least Squares Mean (Standard Error) [% change from baseline: body wt (kg)]	2.79 (0.23)	5.38 (0.31)	1.15 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lorcaserin 10 mg BID, Matching Placebo BID
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion (%)
	Estimated Value	-2.58
	Confidence Interval	(2-Sided) 95%; -3.29 to -1.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lorcaserin 10 mg BID, Placebo (Yr 1) / Placebo (Yr 2)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion (%)
	Estimated Value	1.64
	Confidence Interval	(2-Sided) 95%; 1.10 to 2.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data was collected for a period of up to 2 years. The data is separated by group and by year and is inclusive for each year.
Arm/Group Title	Year 1 - Lorcaserin 10 mg BID		Year 1 - Matching Placebo BID		Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)		Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)		Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
Arm/Group Description	lorcaserin 10 mg BID tablets		matching placebo tablets		lorcaserin 10 mg BID tablets		lorcaserin 10 mg BID tablets, matching placebo tablets		matching placebo tablets
All Cause Mortality
	Year 1 - Lorcaserin 10 mg BID		Year 1 - Matching Placebo BID		Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)		Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)		Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Year 1 - Lorcaserin 10 mg BID		Year 1 - Matching Placebo BID		Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)		Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)		Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/1593 (2.4%)		37/1584 (2.3%)		15/573 (2.6%)		6/283 (2.1%)		24/697 (3.4%)
Cardiac disorders
Angina unstable	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Atrial fibrillation	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	2
Coronary artery occlusion	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	1/697 (0.1%)	1
Myocardial infarction	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Supraventricular tachycardia	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Congenital, familial and genetic disorders
Multiple congenital abnormalities	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Eye disorders
Retinal exudates	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Retinal haemorrhage	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Gastrointestinal disorders
Abdominal hernia	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Abdominal pain	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Colitis	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Enterocele	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Gastritis	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Gastrooesophageal reflux disease	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Oesophagitis	2/1593 (0.1%)	2	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Rectal prolapse	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
General disorders
Chest pain	1/1593 (0.1%)	1	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Hepatobiliary disorders
Biliary dyskinesia	0/1593 (0%)	0	1/1584 (0.1%)	1	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Cholecystitis	1/1593 (0.1%)	1	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Cholecystitis acute	2/1593 (0.1%)	2	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Cholecystitis chronic	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Cholelithiasis	0/1593 (0%)	0	2/1584 (0.1%)	2	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Immune system disorders
Drug hypersensitivity	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Infections and infestations
Abscess	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	0/697 (0%)	0
Cellulitis	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Clostridium difficile colitis	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Diverticulitis	2/1593 (0.1%)	3	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Epiglottitis	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Giardiasis	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Laryngitis	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Lobar pneumonia	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Mastoiditis	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Osteomyelitis	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Pneumonia	1/1593 (0.1%)	1	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Sinusitis	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Injury, poisoning and procedural complications
Ankle fracture	0/1593 (0%)	0	2/1584 (0.1%)	2	1/573 (0.2%)	1	0/283 (0%)	0	1/697 (0.1%)	1
Clavicle fracture	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Concussion	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Femur fracture	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Fibula fracture	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Gun shot wound	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Incisional hernia	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Intentional overdose	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	0/697 (0%)	0
Ligament rupture	1/1593 (0.1%)	1	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Lower limb fracture	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Meniscus lesion	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Muscle strain	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Road traffic accident	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Spinal fracture	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Subdural haemorrhage	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Tibia fracture	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Traumatic brain injury	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Investigations
Blood pressure increased	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Back pain	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Intervertebral disc degeneration	1/1593 (0.1%)	1	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Intervertebral disc disorder	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Intervertebral disc protusion	2/1593 (0.1%)	2	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Loose body in joint	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Musculoskeletal pain	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Osteoarthritis	1/1593 (0.1%)	1	3/1584 (0.2%)	3	2/573 (0.3%)	2	1/283 (0.4%)	2	1/697 (0.1%)	1
Rotator cuff syndrome	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Tendon disorder	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Tendonitis	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	0/1593 (0%)	0	2/1584 (0.1%)	2	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Breast cancer	0/1593 (0%)	0	3/1584 (0.2%)	3	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Carcinoid tumour	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Colon cancer	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	0/697 (0%)	0
Lung adenocarcinoma	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Papillary thyroid cancer	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Pituitary tumour benign	0/1593 (0%)	0	0/1584 (0%)	0	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Prostate cancer	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	0/697 (0%)	0
Squamous cell carcinoma	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Teratoma benign	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Uterine leiomyoma	0/1593 (0%)	0	2/1584 (0.1%)	2	1/573 (0.2%)	1	0/283 (0%)	0	3/697 (0.4%)	3
Nervous system disorders
Dysphasia	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Migraine	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Nervous system disorder	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Paraesthesia	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Radiculitis	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Radiculopathy	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Subarachnoid haemorrhage	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Syncope	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Syncope vasovagal	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Transient ischaemic attack	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Psychiatric disorders
Suicide attempt	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Renal and urinary disorders
Urinary incontinence	0/1593 (0%)	0	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	1/697 (0.1%)	1
Reproductive system and breast disorders
Breast hyperplasia	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Cystocele	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Dysmenorrhoea	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Menometrorrhagia	1/1593 (0.1%)	1	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Menorrhagia	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	0/697 (0%)	0
Rectocele	1/1593 (0.1%)	1	0/1584 (0%)	0	2/573 (0.3%)	2	0/283 (0%)	0	0/697 (0%)	0
Uterine haemorrhage	1/1593 (0.1%)	1	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Uterine malposition	0/1593 (0%)	0	1/1584 (0.1%)	1	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Uterine prolapse	0/1593 (0%)	0	1/1584 (0.1%)	1	1/573 (0.2%)	1	0/283 (0%)	0	0/697 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchospasm	1/1593 (0.1%)	1	0/1584 (0%)	0	0/573 (0%)	0	0/283 (0%)	0	0/697 (0%)	0
Pulmonary embolism	2/1593 (0.1%)	2	0/1584 (0%)	0	0/573 (0%)	0	1/283 (0.4%)	1	1/697 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Year 1 - Lorcaserin 10 mg BID		Year 1 - Matching Placebo BID		Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)		Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)		Year 2 - Placebo (Yr 1) / Placebo (Yr 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1324/1593 (83.1%)		1203/1584 (75.9%)		450/573 (78.5%)		210/283 (74.2%)		515/697 (73.9%)
Gastrointestinal disorders
Constipation	106/1593 (6.7%)	116	64/1584 (4%)	72	14/573 (2.4%)	16	8/283 (2.8%)	9	11/697 (1.6%)	11
Diarrhoea	109/1593 (6.8%)	118	85/1584 (5.4%)	100	34/573 (5.9%)	38	9/283 (3.2%)	10	30/697 (4.3%)	31
Dry mouth	83/1593 (5.2%)	84	37/1584 (2.3%)	37	1/573 (0.2%)	1	3/283 (1.1%)	3	2/697 (0.3%)	2
Nausea	119/1593 (7.5%)	141	85/1584 (5.4%)	90	20/573 (3.5%)	20	9/283 (3.2%)	9	29/697 (4.2%)	32
General disorders
Fatigue	95/1593 (6%)	108	48/1584 (3%)	51	15/573 (2.6%)	15	5/283 (1.8%)	6	16/697 (2.3%)	17
Infections and infestations
Gastroenteritis viral	79/1593 (5%)	87	64/1584 (4%)	67	18/573 (3.1%)	18	14/283 (4.9%)	14	21/697 (3%)	25
Influenza	73/1593 (4.6%)	81	69/1584 (4.4%)	72	38/573 (6.6%)	39	14/283 (4.9%)	15	42/697 (6%)	44
Nasopharyngitis	213/1593 (13.4%)	249	190/1584 (12%)	223	94/573 (16.4%)	114	39/283 (13.8%)	45	88/697 (12.6%)	103
Sinusitis	114/1593 (7.2%)	139	130/1584 (8.2%)	152	49/573 (8.6%)	62	30/283 (10.6%)	33	48/697 (6.9%)	59
Upper respiratory tract infection	235/1593 (14.8%)	280	189/1584 (11.9%)	216	83/573 (14.5%)	100	31/283 (11%)	41	112/697 (16.1%)	131
Urinary tract infection	106/1593 (6.7%)	132	96/1584 (6.1%)	112	41/573 (7.2%)	48	14/283 (4.9%)	15	35/697 (5%)	37
Musculoskeletal and connective tissue disorders
Arthralgia	70/1593 (4.4%)	79	75/1584 (4.7%)	87	38/573 (6.6%)	44	17/283 (6%)	18	43/697 (6.2%)	51
Back pain	99/1593 (6.2%)	114	89/1584 (5.6%)	93	34/573 (5.9%)	39	16/283 (5.7%)	19	30/697 (4.3%)	33
Nervous system disorders
Dizziness	130/1593 (8.2%)	149	60/1584 (3.8%)	69	10/573 (1.7%)	11	8/283 (2.8%)	8	17/697 (2.4%)	17
Headache	287/1593 (18%)	388	175/1584 (11%)	211	41/573 (7.2%)	49	18/283 (6.4%)	25	30/697 (4.3%)	42

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.