Trial Outcomes & Findings for CT-011 MAb in DLBCL Patients Following ASCT (NCT NCT00532259)
NCT ID: NCT00532259
Last Updated: 2014-09-12
Results Overview
PFS (progression-free survival ) will be determined at the eligible patient populations
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
Results posted on
2014-09-12
Participant Flow
22 February 2008 (first patient enrolled) to 02 June 2011 (last patient completed) The study was carried out in medical centers
Participant milestones
| Measure |
CT-011 Antibody
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
CT-011 Antibody
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
21
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
CT-011 MAb in DLBCL Patients Following ASCT
Baseline characteristics by cohort
| Measure |
CT-011 Antibody
n=72 Participants
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=93 Participants
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 13.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=93 Participants
|
|
Region of Enrollment
Israel
|
10 participants
n=93 Participants
|
|
Region of Enrollment
India
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).Population: Patients who did not meet key study entry criteria were excluded from the eligible data set.
PFS (progression-free survival ) will be determined at the eligible patient populations
Outcome measures
| Measure |
CT-011 Antibody
n=66 Participants
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Progression-free Survival
|
72 Percent
Interval 60.0 to 82.0
|
SECONDARY outcome
Timeframe: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).Outcome measures
| Measure |
CT-011 Antibody
n=66 Participants
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Overall Survival
|
85 Percent
Interval 78.0 to 93.0
|
Adverse Events
CT-011 Antibody
Serious events: 23 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-011 Antibody
n=72 participants at risk
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
6/72 • Number of events 7 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
2/72 • Number of events 4 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Pyrexia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Osteomyelitis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Herpes zoster
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Herpes zoster disseminated
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
H1n1 Influenza
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Lobar pneumonia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Vascular injury
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Accident
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Biopsy Lymph Gland
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Laparoscopy
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Surgical and medical procedures
Cholecystectomy
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Surgical and medical procedures
Abdominal Hernia Repair
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Surgical and medical procedures
Knee Arthroplasty
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Surgical and medical procedures
Small Intestinal Resection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
Other adverse events
| Measure |
CT-011 Antibody
n=72 participants at risk
CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.2%
5/69 • Number of events 6 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
5/72 • Number of events 7 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.9%
5/72 • Number of events 5 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.1%
13/72 • Number of events 18 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Idiopathic Thrombocytopenic Purpura
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
8/72 • Number of events 11 • 3 years, 3 months
|
|
Cardiac disorders
Palpitations
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Cardiac disorders
Sinus Bradycardia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Cardiac disorders
Sinus Tachycardia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Endocrine disorders
Hypothyroidism
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Eye disorders
Blindness
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Eye disorders
Cataract
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Eye disorders
Conjunctivitis Allergic
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Eye disorders
Eye Oedema
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Eye disorders
Periorbital Oedema
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Eye disorders
Eye Pruritus
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Eye disorders
Vision Blurred
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Eye disorders
Visual Impairment
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Rectal Ulcer
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
12/72 • Number of events 19 • 3 years, 3 months
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Gastrointestinal disorders
Defaecation Urgency
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
8/72 • Number of events 9 • 3 years, 3 months
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
4/72 • Number of events 6 • 3 years, 3 months
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Gastrointestinal disorders
Dry Mouth
|
2.8%
2/72 • Number of events 3 • 3 years, 3 months
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Asthenia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Fatigue
|
25.0%
18/72 • Number of events 21 • 3 years, 3 months
|
|
General disorders
Pyrexia
|
11.1%
8/72 • Number of events 10 • 3 years, 3 months
|
|
General disorders
Chills
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
General disorders
Feeling Cold
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
General Physical Health Deterioration
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Influenza Like Illness
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Local Swelling
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Oedema Peripheral
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Chest Discomfort
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
General disorders
Chest Pain
|
1.4%
1/72 • Number of events 2 • 3 years, 3 months
|
|
General disorders
Facial Pain
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
General disorders
Pain
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Hepatobiliary disorders
Hepatitis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Immune system disorders
Seasonal Allergy
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Enterocolitis Infectious
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Folliculitis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Candidiasis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Clostridial Infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Tooth Abscess
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Ear Infection
|
1.4%
1/72 • Number of events 2 • 3 years, 3 months
|
|
Infections and infestations
Fungal Infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Gastrointestinal Fungal Infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Oral Fungal Infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Helicobacter Infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Herpes Zoster
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Infections and infestations
Oral Herpes
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Abscess Limb
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Influenza
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Infections and infestations
Bronchitis
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Infections and infestations
Lung Infection
|
1.4%
1/72 • Number of events 2 • 3 years, 3 months
|
|
Infections and infestations
Pneumonia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Skin Infection
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Infections and infestations
Chronic Sinusitis
|
1.4%
1/72 • Number of events 2 • 3 years, 3 months
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
2/72 • Number of events 3 • 3 years, 3 months
|
|
Infections and infestations
Rhinitis
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Infections and infestations
Sinusitis
|
8.3%
6/72 • Number of events 9 • 3 years, 3 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
19.4%
14/72 • Number of events 15 • 3 years, 3 months
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Infections and infestations
Viral Rash
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Anxiety Postoperative
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Seroma
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Contusion
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Blood Cholesterol Increased
|
1.4%
1/72 • Number of events 2 • 3 years, 3 months
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
5.6%
4/72 • Number of events 7 • 3 years, 3 months
|
|
Investigations
International Normalised Ratio
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
International Normalised Ratio Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Electrocardiogram Abnormal
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Alanine Aminotransferase Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Investigations
Hepatic Enzyme Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Liver Function Test Abnormal
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Blood Phosphorus Decreased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Blood Potassium Decreased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Blood Sodium Decreased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Blood Sodium Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Serum Ferritin Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Lymph Node Palpable
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Weight Decreased
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Investigations
Weight Increased
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Platelet Count Decreased
|
6.9%
5/72 • Number of events 5 • 3 years, 3 months
|
|
Investigations
Haemoglobin Decreased
|
12.5%
9/72 • Number of events 9 • 3 years, 3 months
|
|
Investigations
Blood Creatinine Increased
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Investigations
Blood Testosterone Decreased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Biopsy Prostate Normal
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
2.8%
2/72 • Number of events 3 • 3 years, 3 months
|
|
Investigations
Neutrophil Count Decreased
|
8.3%
6/72 • Number of events 7 • 3 years, 3 months
|
|
Investigations
White Blood Cell Count Decreased
|
12.5%
9/72 • Number of events 12 • 3 years, 3 months
|
|
Investigations
White Blood Cell Count Increased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.9%
5/72 • Number of events 5 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.6%
4/72 • Number of events 5 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
9/72 • Number of events 12 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.4%
1/72 • Number of events 2 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.8%
2/72 • Number of events 3 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Bursa Disorder
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
5/72 • Number of events 5 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
4/72 • Number of events 5 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.2%
3/72 • Number of events 4 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma Recurrent
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Haemorrhage Intracranial
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Somnolence
|
4.2%
3/72 • Number of events 6 • 3 years, 3 months
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Viith Nerve Paralysis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Headache
|
8.3%
6/72 • Number of events 8 • 3 years, 3 months
|
|
Nervous system disorders
Sinus Headache
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Memory Impairment
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Dizziness
|
8.3%
6/72 • Number of events 6 • 3 years, 3 months
|
|
Nervous system disorders
Presyncope
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Nervous system disorders
Muscle Contractions Involuntary
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Nervous system disorders
Paraesthesia
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
6.9%
5/72 • Number of events 5 • 3 years, 3 months
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Neuralgia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Restless Legs Syndrome
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Dysarthria
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Nervous system disorders
Tremor
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Psychiatric disorders
Anxiety
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Psychiatric disorders
Depression
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Psychiatric disorders
Insomnia
|
9.7%
7/72 • Number of events 7 • 3 years, 3 months
|
|
Psychiatric disorders
Libido Decreased
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Renal and urinary disorders
Dysuria
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Renal and urinary disorders
Micturition Urgency
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Renal and urinary disorders
Renal Failure
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Renal and urinary disorders
Renal Cyst
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Renal and urinary disorders
Glycosuria
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Renal and urinary disorders
Nocturia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Reproductive system and breast disorders
Nipple Pain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Reproductive system and breast disorders
Sexual Dysfunction
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
5/72 • Number of events 5 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
12/72 • Number of events 14 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Sinusitis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
4.2%
3/72 • Number of events 4 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
4/72 • Number of events 4 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia Facial
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Macule
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Scar Pain
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
3/72 • Number of events 4 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
6/72 • Number of events 7 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Surgical and medical procedures
Lymphadenectomy
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Vascular disorders
Aortic Aneurysm
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Vascular disorders
Haematoma
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Vascular disorders
Flushing
|
1.4%
1/72 • Number of events 1 • 3 years, 3 months
|
|
Vascular disorders
Hot Flush
|
2.8%
2/72 • Number of events 2 • 3 years, 3 months
|
|
Vascular disorders
Hypertension
|
4.2%
3/72 • Number of events 3 • 3 years, 3 months
|
|
Vascular disorders
Hypotension
|
9.7%
7/72 • Number of events 9 • 3 years, 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place