Trial Outcomes & Findings for Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) (NCT NCT01355484)
NCT ID: NCT01355484
Last Updated: 2016-03-03
Results Overview
Measure is the percentage of subjects at day 84 with stair climb power change \>=10% from their baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
Day 84
Results posted on
2016-03-03
Participant Flow
Participant milestones
| Measure |
GTx-024
subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
|
Placebo
subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
161
|
|
Overall Study
COMPLETED
|
109
|
107
|
|
Overall Study
NOT COMPLETED
|
51
|
54
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
GTx-024
n=160 Participants
subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
|
Placebo
n=161 Participants
subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
n=93 Participants
|
62.0 years
n=4 Participants
|
61.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=93 Participants
|
115 Participants
n=4 Participants
|
232 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: Subjects included in the Full Analysis Set
Measure is the percentage of subjects at day 84 with stair climb power change \>=10% from their baseline value.
Outcome measures
| Measure |
GTx-024
n=160 Participants
subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
|
Placebo
n=161 Participants
subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial
|
|---|---|---|
|
Physical Function
|
29.4 percentage of subjects
Interval 22.4 to 37.1
|
24.2 percentage of subjects
Interval 17.8 to 31.6
|
PRIMARY outcome
Timeframe: Day 84Population: Subjects included in the Full Analysis Set
Measure is the percentage of subjects at day 84 with lean body mass change \>=0% from their baseline value.
Outcome measures
| Measure |
GTx-024
n=160 Participants
subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
|
Placebo
n=161 Participants
subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial
|
|---|---|---|
|
Lean Body Mass
|
41.9 percentage of subjects
Interval 34.1 to 49.9
|
30.4 percentage of subjects
Interval 23.4 to 38.2
|
Adverse Events
GTx-024
Serious events: 56 serious events
Other events: 141 other events
Deaths: 0 deaths
Placebo
Serious events: 60 serious events
Other events: 144 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GTx-024
n=160 participants at risk
subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
|
Placebo
n=161 participants at risk
subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial
|
|---|---|---|
|
General disorders
Disease Progression
|
11.9%
19/160 • Number of events 20 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
9.9%
16/161 • Number of events 16 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Condition Aggravated
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Death
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
General Physical Health Deterioration
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Non-Cardiac Chest Pain
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
2/160 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
2.5%
4/161 • Number of events 4 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
3/160 • Number of events 4 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 3 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
3/160 • Number of events 3 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 3 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.2%
2/160 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.2%
2/160 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.9%
3/161 • Number of events 3 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
4/160 • Number of events 4 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
3.1%
5/161 • Number of events 5 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
3/160 • Number of events 4 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
2.5%
4/161 • Number of events 6 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.5%
4/160 • Number of events 4 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Pneumonia
|
3.8%
6/160 • Number of events 6 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
2.5%
4/161 • Number of events 4 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Urinary Tract Infection
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Bronchitis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Infectious Pleural Effusion
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Respiratory Tract Infection
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Viral Infection
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.2%
2/161 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Dysphagia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
3.7%
6/161 • Number of events 7 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Dee Vein Thrombosis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
1.9%
3/161 • Number of events 3 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Orthostatic Hypertension
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Subclavian Artery Thrombosis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Thrombosis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Vascular disorders
Venous Thrombosis
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
2/160 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Cardiac Failure
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Injury, poisoning and procedural complications
Radiation Oesophagitis
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Injury, poisoning and procedural complications
Open Fracture
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Injury, poisoning and procedural complications
Radiation Injury
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Injury, poisoning and procedural complications
Radiation Pneumonitis
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Meninges
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Nervous system disorders
Syncope
|
1.2%
2/160 • Number of events 2 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Nervous system disorders
Cerebral Infarction
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Investigations
Neutrophil Count Decreased
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Psychiatric disorders
Completed Suicide
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Psychiatric disorders
Delusional Disorder, Persecutory Type
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Renal and urinary disorders
Renal Failure
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/160 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.62%
1/161 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Surgical and medical procedures
Abdominal Operation
|
0.62%
1/160 • Number of events 1 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
0.00%
0/161 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
Other adverse events
| Measure |
GTx-024
n=160 participants at risk
subject will receive GTx-024 treatment for the duration of the trial
GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
|
Placebo
n=161 participants at risk
subject will receive placebo for the duration of the trial
placebo: subject will receive placebo for the duration of the trial
|
|---|---|---|
|
General disorders
Disease Progression
|
13.8%
22/160 • Number of events 24 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
19.9%
32/161 • Number of events 36 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Asthenia
|
20.6%
33/160 • Number of events 43 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
12.4%
20/161 • Number of events 31 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Fatigue
|
12.5%
20/160 • Number of events 36 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
13.7%
22/161 • Number of events 30 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Pyrexia
|
7.5%
12/160 • Number of events 14 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
8.7%
14/161 • Number of events 18 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
General disorders
Chest Pain
|
5.0%
8/160 • Number of events 10 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
7.5%
12/161 • Number of events 13 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Nausea
|
35.6%
57/160 • Number of events 118 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
32.3%
52/161 • Number of events 130 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Vomiting
|
18.1%
29/160 • Number of events 39 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
16.1%
26/161 • Number of events 38 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Diarrhoea
|
11.2%
18/160 • Number of events 33 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
14.9%
24/161 • Number of events 32 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Gastrointestinal disorders
Constipation
|
10.6%
17/160 • Number of events 19 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
6.8%
11/161 • Number of events 14 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Anaemia
|
28.7%
46/160 • Number of events 60 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
27.3%
44/161 • Number of events 62 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
20/160 • Number of events 33 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
18.6%
30/161 • Number of events 44 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.8%
54/160 • Number of events 58 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
32.3%
52/161 • Number of events 62 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
11.9%
19/160 • Number of events 23 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
5.6%
9/161 • Number of events 12 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.2%
10/160 • Number of events 19 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
5.0%
8/161 • Number of events 10 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.1%
21/160 • Number of events 31 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
7.5%
12/161 • Number of events 16 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
11/160 • Number of events 12 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
8.7%
14/161 • Number of events 18 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.4%
7/160 • Number of events 9 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
8.7%
14/161 • Number of events 17 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
27/160 • Number of events 49 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
13.7%
22/161 • Number of events 42 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.1%
13/160 • Number of events 24 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
6.2%
10/161 • Number of events 21 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.1%
13/160 • Number of events 26 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
5.6%
9/161 • Number of events 19 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.9%
11/160 • Number of events 21 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
16.8%
27/161 • Number of events 45 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
|
Infections and infestations
Pneumonia
|
5.0%
8/160 • Number of events 8 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
8.7%
14/161 • Number of events 15 • 1 year, 7 months
Initiation: 26 Oct 2011, Completion: 8 May 2013
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Provide Sponsor with an advance copy of any proposed results communication at least 60 days prior to the date of the planned submission or presentation and Sponsor shall have 60 days from receipt to request any changes. Sponsor may request a delay of up to 60 additional days. The PI shall not present data until the earlier of Sponsor's publication of the results of all investigators participating in the Study or 18 months after completion of the Study at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER