Trial Outcomes & Findings for Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation (NCT NCT00804141)
NCT ID: NCT00804141
Last Updated: 2019-10-18
Results Overview
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1040 participants
Primary outcome timeframe
Baseline up to Week 50
Results posted on
2019-10-18
Participant Flow
A total of 1040 participants who met the inclusion/exclusion criteria were assigned to receive treatment and 1034 of these participants received at least 1 dose of study drug.
Participant milestones
| Measure |
MOA-728 12 mg QD
Participants received N-methylnaltrexone bromide (MOA-728, MNTX) 12 milligrams (mg) subcutaneously (SC) once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Overall Study
STARTED
|
1040
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
1034
|
|
Overall Study
COMPLETED
|
477
|
|
Overall Study
NOT COMPLETED
|
563
|
Reasons for withdrawal
| Measure |
MOA-728 12 mg QD
Participants received N-methylnaltrexone bromide (MOA-728, MNTX) 12 milligrams (mg) subcutaneously (SC) once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Overall Study
Adverse Event
|
157
|
|
Overall Study
Death
|
4
|
|
Overall Study
Failed to return
|
96
|
|
Overall Study
Investigator request
|
8
|
|
Overall Study
Protocol Violation
|
85
|
|
Overall Study
Withdrawal by Subject
|
131
|
|
Overall Study
Lack of Efficacy
|
46
|
|
Overall Study
Other than specified
|
30
|
|
Overall Study
Enrolled but not treated
|
6
|
Baseline Characteristics
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Baseline characteristics by cohort
| Measure |
MOA-728 12 mg QD
n=1034 Participants
Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Age, Continuous
|
51.67 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
669 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
365 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 50Population: All participants who received at least one dose of study drug.
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
MOA-728 12 mg QD
n=1034 Participants
Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAEs
|
817 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
SAEs
|
104 Participants
|
SECONDARY outcome
Timeframe: Baseline, follow-up (14 days [Week 49 to 50])Population: All participants who received at least one dose of study drug. Here, 'Number analyzed' signifies participants evaluable at specified timepoint.
Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing.
Outcome measures
| Measure |
MOA-728 12 mg QD
n=1034 Participants
Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up
Baseline
|
3.9 BM/week
Standard Deviation 2.8
|
|
Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up
Change during follow-up
|
0.5 BM/week
Standard Deviation 2.7
|
Adverse Events
MOA-728 12 mg QD
Serious events: 104 serious events
Other events: 564 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MOA-728 12 mg QD
n=1034 participants at risk
Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.29%
3/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Prinzmetal angina
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Eye disorders
Choroiditis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Eye disorders
Ulcerative keratitis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
3/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal dilatation
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Abasia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Device dislocation
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Polyarteritis nodosa
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Perihepatic abscess
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.77%
8/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium decreased
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
3/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.48%
5/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Head discomfort
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Nerve compression
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Radiculopathy
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.29%
3/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol abuse
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Intentional drug misuse
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.15%
1/669 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
4/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Granuloma skin
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.10%
1/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.19%
2/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
MOA-728 12 mg QD
n=1034 participants at risk
Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
24.0%
248/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
69/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.5%
171/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
15.3%
158/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
57/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
77/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
6.2%
64/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.4%
56/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
61/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
65/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.8%
60/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.0%
93/1034 • Baseline up to Week 50
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER