Trial Outcomes & Findings for Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD) (NCT NCT00926575)
NCT ID: NCT00926575
Last Updated: 2013-12-06
Results Overview
The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
Day 80
Results posted on
2013-12-06
Participant Flow
Participant milestones
| Measure |
Active
oral beclomethasone 17,21-dipropionate (BDP)
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
| Measure |
Active
oral beclomethasone 17,21-dipropionate (BDP)
|
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
Baseline Characteristics
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Baseline characteristics by cohort
| Measure |
Active
n=70 Participants
oral beclomethasone 17,21-dipropionate (BDP)
|
Placebo
n=70 Participants
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 80Population: Data was not analyzed as the study was terminated due to futility
The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 80Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 200Outcome measures
Outcome data not reported
Adverse Events
Active
Serious events: 32 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo
Serious events: 28 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=70 participants at risk
oral beclomethasone 17,21-dipropionate (BDP)
|
Placebo
n=70 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute myeloid leukemia progression
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Angiopathic Anemia
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Leukemic Relapse
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Multiple myeloma progression
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Recurrent AML
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Relapsed ALL
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Relapsed AML
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic purpura
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
General disorders
Disease Progression
|
1.4%
1/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
General disorders
DVT
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
General disorders
Fatigue
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
General disorders
Fever
|
2.9%
2/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
General disorders
Flank Pain
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
General disorders
Multi-organ failure
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
General disorders
Progressive disease
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Abdominal Cramps
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
4/70 • Day 1 to Day 80
|
2.9%
2/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Increased Abdominal Cramping
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Intermittent Diarrhea
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Intractable Nausea
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Intractable vomiting
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Loose Stool
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Peritoneal Perforation
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Watery Diarrhea
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Immune system disorders
Acute GVHD flare
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Immune system disorders
Lower GI GVHD
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Back Pain
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
BK Viruria
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
BK Virus Cystitis
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
BK Virus Infection
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Clostridium difficile infection
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
CMV infection
|
2.9%
2/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
CMV infection/reactivation
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
CMV Pneumonitis
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
CMV reaction
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
CMV Reactivation
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Gram Negative Bacilli Hyperbilirubinemia
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Gram Negative Bacteremia
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Gram Positive Bacteremia
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Lower Extremities Cellulitis
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Nocardia sepsis
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Pneumonia fungal
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Right orbital cellulitis
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Rotavirus infection
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Septic Pneumonia
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Septic Shock
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Skin GVHD
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Staph Bacteremia
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Viral Respiratory-type Infection
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Investigations
RSV Positive
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Poor PO Intake
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
2/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Pain: Bone Diffuse
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Nervous system disorders
Dizziness
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Nervous system disorders
Meningismus
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Nervous system disorders
Seizure
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Psychiatric disorders
Mental Status Changes
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Renal and urinary disorders
Acute Renal Failure
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Renal and urinary disorders
Renal failure
|
2.9%
2/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress with Respiratory Failure
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Tachyarrhythmia absoluta
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Vascular disorders
Hypertension Worsened
|
0.00%
0/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
Other adverse events
| Measure |
Active
n=70 participants at risk
oral beclomethasone 17,21-dipropionate (BDP)
|
Placebo
n=70 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
5/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
7/70 • Day 1 to Day 80
|
10.0%
7/70 • Day 1 to Day 80
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
12.9%
9/70 • Day 1 to Day 80
|
8.6%
6/70 • Day 1 to Day 80
|
|
Cardiac disorders
Tachycardia
|
5.7%
4/70 • Day 1 to Day 80
|
8.6%
6/70 • Day 1 to Day 80
|
|
Endocrine disorders
Adrenal insufficiency
|
5.7%
4/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Eye disorders
Dry Eye
|
10.0%
7/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Eye disorders
Vision Blurred
|
7.1%
5/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
20/70 • Day 1 to Day 80
|
20.0%
14/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Constipation
|
7.1%
5/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Diarrhoea
|
47.1%
33/70 • Day 1 to Day 80
|
24.3%
17/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Dry Mouth
|
12.9%
9/70 • Day 1 to Day 80
|
11.4%
8/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
5/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
5/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Nausea
|
31.4%
22/70 • Day 1 to Day 80
|
30.0%
21/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Retching
|
4.3%
3/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
12/70 • Day 1 to Day 80
|
24.3%
17/70 • Day 1 to Day 80
|
|
General disorders
Asthenia
|
10.0%
7/70 • Day 1 to Day 80
|
8.6%
6/70 • Day 1 to Day 80
|
|
General disorders
Early Satiety
|
5.7%
4/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
General disorders
Chills
|
2.9%
2/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
General disorders
Fatigue
|
24.3%
17/70 • Day 1 to Day 80
|
31.4%
22/70 • Day 1 to Day 80
|
|
General disorders
Oedema
|
4.3%
3/70 • Day 1 to Day 80
|
2.9%
2/70 • Day 1 to Day 80
|
|
General disorders
Oedema Peripheral
|
8.6%
6/70 • Day 1 to Day 80
|
11.4%
8/70 • Day 1 to Day 80
|
|
Gastrointestinal disorders
Pyrexia
|
17.1%
12/70 • Day 1 to Day 80
|
12.9%
9/70 • Day 1 to Day 80
|
|
Immune system disorders
Acute graft versus host disease in skin
|
7.1%
5/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Immune system disorders
Hypogammagluobulinaemia
|
8.6%
6/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Infections and infestations
Bacteraemia
|
8.6%
6/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
BK virus infection
|
7.1%
5/70 • Day 1 to Day 80
|
2.9%
2/70 • Day 1 to Day 80
|
|
Infections and infestations
Clostridial infection
|
5.7%
4/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Infections and infestations
Cytomegalovirus infection
|
21.4%
15/70 • Day 1 to Day 80
|
15.7%
11/70 • Day 1 to Day 80
|
|
Infections and infestations
Cytomegalovirus viraemia
|
7.1%
5/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Infections and infestations
Epstein- Barr virus infection
|
5.7%
4/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
2/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Investigations
Blood Creatinine increased
|
7.1%
5/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Investigations
Breath sounds abnormal
|
4.3%
3/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Investigations
Hepatic enzyme increased
|
4.3%
3/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Investigations
Blood lactate dehyrogenase increase
|
1.4%
1/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Investigations
Neutrophil count increased
|
0.00%
0/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Investigations
Protein total decreased
|
1.4%
1/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Investigations
Transaminases increased
|
2.9%
2/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Investigations
Weight decreased
|
11.4%
8/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
7/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Cushingoid
|
7.1%
5/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.9%
16/70 • Day 1 to Day 80
|
18.6%
13/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
3/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Fluid retension
|
4.3%
3/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.7%
11/70 • Day 1 to Day 80
|
17.1%
12/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.9%
9/70 • Day 1 to Day 80
|
12.9%
9/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.9%
2/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.4%
1/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
8/70 • Day 1 to Day 80
|
12.9%
9/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.6%
6/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
5/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.3%
3/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
4/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.3%
3/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.3%
3/70 • Day 1 to Day 80
|
8.6%
6/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
4/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
4/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Nervous system disorders
Dizziness
|
4.3%
3/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Nervous system disorders
Dysgeusia
|
4.3%
3/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Nervous system disorders
Headache
|
12.9%
9/70 • Day 1 to Day 80
|
12.9%
9/70 • Day 1 to Day 80
|
|
Nervous system disorders
Neuropathy peripheral
|
2.9%
2/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
|
Nervous system disorders
Tremor
|
10.0%
7/70 • Day 1 to Day 80
|
11.4%
8/70 • Day 1 to Day 80
|
|
Psychiatric disorders
Anxiety
|
5.7%
4/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Psychiatric disorders
Depression
|
10.0%
7/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Psychiatric disorders
Insomnia
|
12.9%
9/70 • Day 1 to Day 80
|
12.9%
9/70 • Day 1 to Day 80
|
|
Renal and urinary disorders
Dysuria
|
4.3%
3/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Renal and urinary disorders
Haematuria
|
4.3%
3/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
3/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Renal and urinary disorders
Renal failure
|
11.4%
8/70 • Day 1 to Day 80
|
8.6%
6/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
4/70 • Day 1 to Day 80
|
17.1%
12/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
3/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.1%
5/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Epstaxis
|
4.3%
3/70 • Day 1 to Day 80
|
2.9%
2/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.7%
4/70 • Day 1 to Day 80
|
2.9%
2/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.3%
3/70 • Day 1 to Day 80
|
2.9%
2/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/70 • Day 1 to Day 80
|
10.0%
7/70 • Day 1 to Day 80
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.4%
1/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.6%
6/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.7%
4/70 • Day 1 to Day 80
|
0.00%
0/70 • Day 1 to Day 80
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.7%
4/70 • Day 1 to Day 80
|
11.4%
8/70 • Day 1 to Day 80
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
5/70 • Day 1 to Day 80
|
7.1%
5/70 • Day 1 to Day 80
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
9/70 • Day 1 to Day 80
|
14.3%
10/70 • Day 1 to Day 80
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
2.9%
2/70 • Day 1 to Day 80
|
4.3%
3/70 • Day 1 to Day 80
|
|
Vascular disorders
Deep vein thrombosis
|
4.3%
3/70 • Day 1 to Day 80
|
1.4%
1/70 • Day 1 to Day 80
|
|
Vascular disorders
Hypertension
|
27.1%
19/70 • Day 1 to Day 80
|
10.0%
7/70 • Day 1 to Day 80
|
|
Vascular disorders
Hypotension
|
4.3%
3/70 • Day 1 to Day 80
|
5.7%
4/70 • Day 1 to Day 80
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER