Trial Outcomes & Findings for BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management (NCT NCT00603902)
NCT ID: NCT00603902
Last Updated: 2019-10-04
Results Overview
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4008 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2019-10-04
Participant Flow
Participant milestones
| Measure |
Lorcaserin 10 mg QD
lorcaserin 10 mg once daily (QD) tablets
|
Lorcaserin 10 mg BID
lorcaserin 10 mg twice a day (BID) tablets
|
Matching Placebo
matching placebo tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
802
|
1603
|
1603
|
|
Overall Study
COMPLETED
|
473
|
917
|
834
|
|
Overall Study
NOT COMPLETED
|
329
|
686
|
769
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
Baseline characteristics by cohort
| Measure |
Lorcaserin 10 mg QD
n=801 Participants
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg BID
n=1602 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo
n=1601 Participants
matching placebo tablets
|
Total
n=4004 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 11.81 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 11.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
656 Participants
n=5 Participants
|
1289 Participants
n=7 Participants
|
1249 Participants
n=5 Participants
|
3194 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
810 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Modified Intent to Treat (MITT) with last observation carried forward (LOCF)
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Outcome measures
| Measure |
Lorcaserin 10 mg QD
n=771 Participants
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg BID
n=1561 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo
n=1541 Participants
matching placebo tablets
|
|---|---|---|---|
|
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
|
40.2 percentage of participants
|
47.2 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: MITT with LOCF
The percent change in body weight (kg) from baseline to week 52.
Outcome measures
| Measure |
Lorcaserin 10 mg QD
n=771 Participants
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg BID
n=1561 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo
n=1541 Participants
matching placebo tablets
|
|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 52
|
-4.75 % change from baseline: body wt (kg)
Standard Error 0.23
|
-5.84 % change from baseline: body wt (kg)
Standard Error 0.16
|
-2.84 % change from baseline: body wt (kg)
Standard Error 0.16
|
Adverse Events
Lorcaserin 10 mg QD
Serious events: 27 serious events
Other events: 653 other events
Deaths: 0 deaths
Lorcaserin 10 mg BID
Serious events: 49 serious events
Other events: 1323 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 36 serious events
Other events: 1205 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorcaserin 10 mg QD
n=801 participants at risk
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg BID
n=1602 participants at risk
lorcaserin 10 mg BID tablets
|
Matching Placebo
n=1601 participants at risk
matching placebo tablets
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
2/801 • Number of events 2 • 52 weeks
|
0.12%
2/1602 • Number of events 2 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/801 • 52 weeks
|
0.12%
2/1602 • Number of events 2 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.12%
2/1601 • Number of events 2 • 52 weeks
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.06%
1/1602 • Number of events 2 • 52 weeks
|
0.12%
2/1601 • Number of events 2 • 52 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
General disorders
Chest pain
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/801 • 52 weeks
|
0.12%
2/1602 • Number of events 2 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Psychiatric disorders
Alcoholic psychosis
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Nervous system disorders
Hypoaesthesia facial
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/801 • 52 weeks
|
0.12%
2/1602 • Number of events 2 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/801 • 52 weeks
|
0.19%
3/1602 • Number of events 3 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.12%
2/1601 • Number of events 2 • 52 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/801 • 52 weeks
|
0.19%
3/1602 • Number of events 3 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Anthropod bite
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Cardiac disorders
Syncope
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/801 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.06%
1/1602 • Number of events 1 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Back injury
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Abscess limb
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Nervous system disorders
Migraine
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Reproductive system and breast disorders
Uterine mass
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Investigations
Heart rate increased
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Oral mucosal hypertrophy
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.25%
2/801 • Number of events 2 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
1/801 • Number of events 2 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Cardiac disorders
Sick sinus syndrome
|
0.12%
1/801 • Number of events 2 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.25%
2/801 • Number of events 2 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.12%
1/801 • Number of events 1 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.12%
2/1601 • Number of events 2 • 52 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.12%
2/1601 • Number of events 2 • 52 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Ovarian necrosis
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Tethered cord syndrome
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.19%
3/1601 • Number of events 3 • 52 weeks
|
|
Renal and urinary disorders
Cystocele
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Rectocele
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.12%
2/1601 • Number of events 2 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage I, with cancer in situ
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/801 • 52 weeks
|
0.00%
0/1602 • 52 weeks
|
0.06%
1/1601 • Number of events 1 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/801 • 52 weeks
|
0.19%
3/1602 • Number of events 3 • 52 weeks
|
0.00%
0/1601 • 52 weeks
|
Other adverse events
| Measure |
Lorcaserin 10 mg QD
n=801 participants at risk
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg BID
n=1602 participants at risk
lorcaserin 10 mg BID tablets
|
Matching Placebo
n=1601 participants at risk
matching placebo tablets
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.6%
61/801 • Number of events 68 • 52 weeks
|
9.1%
145/1602 • Number of events 160 • 52 weeks
|
5.3%
85/1601 • Number of events 96 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
53/801 • Number of events 59 • 52 weeks
|
6.1%
98/1602 • Number of events 119 • 52 weeks
|
5.9%
94/1601 • Number of events 106 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.1%
41/801 • Number of events 44 • 52 weeks
|
5.0%
80/1602 • Number of events 91 • 52 weeks
|
3.8%
61/1601 • Number of events 62 • 52 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
27/801 • Number of events 29 • 52 weeks
|
5.4%
87/1602 • Number of events 90 • 52 weeks
|
2.3%
37/1601 • Number of events 41 • 52 weeks
|
|
General disorders
Fatigue
|
6.6%
53/801 • Number of events 59 • 52 weeks
|
8.4%
134/1602 • Number of events 147 • 52 weeks
|
4.1%
66/1601 • Number of events 71 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
14.6%
117/801 • Number of events 142 • 52 weeks
|
12.7%
204/1602 • Number of events 247 • 52 weeks
|
12.6%
202/1601 • Number of events 238 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
95/801 • Number of events 123 • 52 weeks
|
12.5%
201/1602 • Number of events 240 • 52 weeks
|
12.0%
192/1601 • Number of events 240 • 52 weeks
|
|
Infections and infestations
Sinusitis
|
8.4%
67/801 • Number of events 77 • 52 weeks
|
7.6%
122/1602 • Number of events 141 • 52 weeks
|
7.4%
118/1601 • Number of events 132 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.6%
61/801 • Number of events 80 • 52 weeks
|
6.7%
107/1602 • Number of events 131 • 52 weeks
|
4.8%
77/1601 • Number of events 84 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
55/801 • Number of events 60 • 52 weeks
|
6.3%
101/1602 • Number of events 107 • 52 weeks
|
5.7%
91/1601 • Number of events 107 • 52 weeks
|
|
Nervous system disorders
Headache
|
15.6%
125/801 • Number of events 158 • 52 weeks
|
15.6%
250/1602 • Number of events 293 • 52 weeks
|
9.2%
147/1601 • Number of events 172 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
6.2%
50/801 • Number of events 58 • 52 weeks
|
8.7%
140/1602 • Number of events 169 • 52 weeks
|
3.9%
62/1601 • Number of events 72 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.
- Publication restrictions are in place
Restriction type: OTHER