Trial Outcomes & Findings for Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (NCT NCT01325701)
NCT ID: NCT01325701
Last Updated: 2017-03-31
Results Overview
The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months)
Results posted on
2017-03-31
Participant Flow
A total of 78 subjects were enrolled: 70 were treated with PCI-32765 (ibrutinib) 560 mg daily, and 8 were treated with ibrutinib 840mg daily. All subjects received at least 1 dose of study drug.
Participant milestones
| Measure |
PCI-32765: 560 mg
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
8
|
|
Overall Study
COMPLETED
|
49
|
5
|
|
Overall Study
NOT COMPLETED
|
21
|
3
|
Reasons for withdrawal
| Measure |
PCI-32765: 560 mg
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Rollerover Extension Study
|
4
|
0
|
Baseline Characteristics
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
PCI-32765: 560 mg
n=70 Participants
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
n=8 Participants
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
Total
n=78 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
|
38 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 Years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
64.4 Years
STANDARD_DEVIATION 13.96 • n=7 Participants
|
62.7 Years
STANDARD_DEVIATION 13.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
8 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months)The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator.
Outcome measures
| Measure |
PCI-32765: 560 mg
n=70 Participants
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
n=8 Participants
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Percentage of Patients With an Overall Response to Study Drug
|
24.3 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Adverse events determined to be related to study drug are collected from first dose until study exit (approximately 3 years).Participants will be followed until progression of the disease or start of another anticancer treatment. The clinical database captured all AEs from baseline through end of treatment. Treatment Emergent AEs were collected pre-dose, at the beginning of each cycle and 30 days post last dose of study drug, unless related to study drug.
Outcome measures
| Measure |
PCI-32765: 560 mg
n=70 Participants
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
n=8 Participants
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
|
70 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Performed during the first month of receiving study drug.Population: PK samples were collected in all participants (n=70 and 8 in PCI-32765: 560 mg and 840 mg, respectively). Of these, 59 participants in PCI-32765: 560 mg and 7 in PCI-32765: 840 mg on Cycle 1 Day 8 were evaluable for PK.
Treatment Group 1 PK collection schedule: Cycle 1 Day 1: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 8: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose Treatment Group 2 PK collection schedule: Cycle 1 Day 8: Pre-dose, 1, 2, 4 and 7 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose Cycle 3 Day 1: Pre-dose, 1, 2, and 4 hours post-dose
Outcome measures
| Measure |
PCI-32765: 560 mg
n=59 Participants
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
n=7 Participants
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765
PCI-32765 - Day 8
|
1285 ng*h/mL
Standard Deviation 971
|
1337 ng*h/mL
Standard Deviation 1556
|
|
Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765
PCI-45227 (Metabolite)- Day 8
|
1485 ng*h/mL
Standard Deviation 948
|
1671 ng*h/mL
Standard Deviation 1147
|
Adverse Events
PCI-32765: 560 mg
Serious events: 40 serious events
Other events: 70 other events
Deaths: 0 deaths
PCI-32765: 840 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCI-32765: 560 mg
n=70 participants at risk
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
n=8 participants at risk
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/70
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Splenic lesion
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
2/70
|
0.00%
0/8
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/70
|
0.00%
0/8
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/70
|
12.5%
1/8
|
|
Gastrointestinal disorders
Nausea
|
4.3%
3/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Melaena
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/70
|
12.5%
1/8
|
|
General disorders
Localised oedema
|
2.9%
2/70
|
0.00%
0/8
|
|
General disorders
Pyrexia
|
2.9%
2/70
|
0.00%
0/8
|
|
General disorders
Fatigue
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/70
|
12.5%
1/8
|
|
General disorders
Oedema peripheral
|
1.4%
1/70
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Pneumonia
|
10.0%
7/70
|
12.5%
1/8
|
|
Infections and infestations
Sepsis
|
4.3%
3/70
|
0.00%
0/8
|
|
Infections and infestations
Cytomegalovirus infection
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/70
|
12.5%
1/8
|
|
Infections and infestations
Pseudomonal sepsis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Staphylococcal sepsis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Platelet count decreased
|
1.4%
1/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/70
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
2.9%
2/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
1.4%
1/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
1/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/70
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
7.1%
5/70
|
25.0%
2/8
|
|
Nervous system disorders
Brain mass
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Intraventricular haemorrhage
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal failure
|
2.9%
2/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
2/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
4/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
2/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
1.4%
1/70
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
0.00%
0/70
|
12.5%
1/8
|
Other adverse events
| Measure |
PCI-32765: 560 mg
n=70 participants at risk
Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
|
PCI-32765: 840 mg
n=8 participants at risk
Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
20/70
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.4%
15/70
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
7/70
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
3/70
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/70
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.9%
2/70
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
1.4%
1/70
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
1.4%
1/70
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
1/70
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.4%
1/70
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Splenic lesion
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Bradycardia
|
2.9%
2/70
|
12.5%
1/8
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
2/70
|
0.00%
0/8
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
2/70
|
0.00%
0/8
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Cardiomegaly
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Palpitations
|
1.4%
1/70
|
0.00%
0/8
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/70
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
2/70
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Deafness unilateral
|
1.4%
1/70
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.4%
1/70
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/70
|
0.00%
0/8
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/70
|
12.5%
1/8
|
|
Endocrine disorders
Hypothyroidism
|
1.4%
1/70
|
0.00%
0/8
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Dry eye
|
4.3%
3/70
|
0.00%
0/8
|
|
Eye disorders
Eye pain
|
2.9%
2/70
|
0.00%
0/8
|
|
Eye disorders
Vision blurred
|
2.9%
2/70
|
0.00%
0/8
|
|
Eye disorders
Conjunctival haemorrhage
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Eye discharge
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Eye swelling
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Glaucoma
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Lacrimation increased
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Ocular hyperaemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Eye disorders
Visual impairment
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
28/70
|
37.5%
3/8
|
|
Gastrointestinal disorders
Nausea
|
34.3%
24/70
|
50.0%
4/8
|
|
Gastrointestinal disorders
Constipation
|
15.7%
11/70
|
12.5%
1/8
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
9/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
8/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
8/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
7/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
5/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
4/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
4/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Ascites
|
2.9%
2/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
2/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal mass
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gingivitis ulcerative
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Melaena
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/70
|
12.5%
1/8
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Salivary gland pain
|
1.4%
1/70
|
0.00%
0/8
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Fatigue
|
42.9%
30/70
|
0.00%
0/8
|
|
General disorders
Pyrexia
|
20.0%
14/70
|
12.5%
1/8
|
|
General disorders
Oedema peripheral
|
17.1%
12/70
|
12.5%
1/8
|
|
General disorders
Chills
|
7.1%
5/70
|
12.5%
1/8
|
|
General disorders
Pain
|
7.1%
5/70
|
12.5%
1/8
|
|
General disorders
Asthenia
|
5.7%
4/70
|
0.00%
0/8
|
|
General disorders
Local swelling
|
5.7%
4/70
|
0.00%
0/8
|
|
General disorders
Localised oedema
|
4.3%
3/70
|
0.00%
0/8
|
|
General disorders
Face oedema
|
2.9%
2/70
|
0.00%
0/8
|
|
General disorders
Malaise
|
1.4%
1/70
|
12.5%
1/8
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/70
|
25.0%
2/8
|
|
General disorders
Catheter site erythema
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Chest discomfort
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Chest pain
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Gait disturbance
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Oedema
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Suprapubic pain
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Tenderness
|
1.4%
1/70
|
0.00%
0/8
|
|
General disorders
Vessel puncture site haematoma
|
1.4%
1/70
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
1/70
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Immune system disorders
Hypogammaglobulinaemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Pneumonia
|
11.4%
8/70
|
12.5%
1/8
|
|
Infections and infestations
Urinary tract infection
|
7.1%
5/70
|
12.5%
1/8
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
4/70
|
0.00%
0/8
|
|
Infections and infestations
Sepsis
|
4.3%
3/70
|
0.00%
0/8
|
|
Infections and infestations
Candida infection
|
2.9%
2/70
|
0.00%
0/8
|
|
Infections and infestations
Herpes zoster
|
2.9%
2/70
|
0.00%
0/8
|
|
Infections and infestations
Sinusitis
|
2.9%
2/70
|
0.00%
0/8
|
|
Infections and infestations
Skin infection
|
1.4%
1/70
|
12.5%
1/8
|
|
Infections and infestations
Conjunctivitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Cystitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Cytomegalovirus infection
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/70
|
12.5%
1/8
|
|
Infections and infestations
Furuncle
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Herpes virus infection
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Laryngitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Nail infection
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Paronychia
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Pseudomonal sepsis
|
1.4%
1/70
|
0.00%
0/8
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/70
|
12.5%
1/8
|
|
Infections and infestations
Staphylococcal sepsis
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
5/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
2/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Laceration
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.4%
1/70
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Platelet count decreased
|
15.7%
11/70
|
12.5%
1/8
|
|
Investigations
Alanine aminotransferase increased
|
8.6%
6/70
|
37.5%
3/8
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
7/70
|
25.0%
2/8
|
|
Investigations
Lymphocyte count decreased
|
11.4%
8/70
|
0.00%
0/8
|
|
Investigations
Blood bilirubin increased
|
8.6%
6/70
|
12.5%
1/8
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
5/70
|
12.5%
1/8
|
|
Investigations
International normalised ratio increased
|
8.6%
6/70
|
0.00%
0/8
|
|
Investigations
White blood cell count decreased
|
8.6%
6/70
|
0.00%
0/8
|
|
Investigations
Blood creatinine increased
|
7.1%
5/70
|
0.00%
0/8
|
|
Investigations
Neutrophil count decreased
|
5.7%
4/70
|
12.5%
1/8
|
|
Investigations
Weight decreased
|
5.7%
4/70
|
0.00%
0/8
|
|
Investigations
Weight increased
|
2.9%
2/70
|
12.5%
1/8
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.9%
2/70
|
0.00%
0/8
|
|
Investigations
Amylase increased
|
0.00%
0/70
|
12.5%
1/8
|
|
Investigations
Blood uric acid increased
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Cardiac murmur
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Lipase increased
|
0.00%
0/70
|
12.5%
1/8
|
|
Investigations
Prothrombin time prolonged
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Transaminases increased
|
1.4%
1/70
|
0.00%
0/8
|
|
Investigations
Urine output decreased
|
1.4%
1/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
14/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.6%
13/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
15.7%
11/70
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
10/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.9%
9/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.4%
8/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
8/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
5/70
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.1%
5/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
4/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.7%
4/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.3%
3/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.9%
2/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.9%
2/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
2/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.4%
1/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/70
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.4%
1/70
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.4%
1/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
10/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
10/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
7/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.6%
6/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
4/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.3%
3/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
2/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
2/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.9%
2/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.9%
2/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
2.9%
2/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
1.4%
1/70
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.4%
1/70
|
0.00%
0/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
7.1%
5/70
|
25.0%
2/8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness
|
10.0%
7/70
|
25.0%
2/8
|
|
Nervous system disorders
Headache
|
10.0%
7/70
|
0.00%
0/8
|
|
Nervous system disorders
Dysgeusia
|
2.9%
2/70
|
0.00%
0/8
|
|
Nervous system disorders
Tremor
|
2.9%
2/70
|
0.00%
0/8
|
|
Nervous system disorders
Brain mass
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Cognitive disorder
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Disturbance in attention
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness postural
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Intraventricular haemorrhage
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Lethargy
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Memory impairment
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/70
|
12.5%
1/8
|
|
Nervous system disorders
Somnolence
|
1.4%
1/70
|
0.00%
0/8
|
|
Nervous system disorders
Syncope
|
1.4%
1/70
|
0.00%
0/8
|
|
Psychiatric disorders
Insomnia
|
10.0%
7/70
|
37.5%
3/8
|
|
Psychiatric disorders
Anxiety
|
7.1%
5/70
|
0.00%
0/8
|
|
Psychiatric disorders
Anxiety disorder due to a general medical condition
|
1.4%
1/70
|
0.00%
0/8
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/70
|
0.00%
0/8
|
|
Psychiatric disorders
Delirium
|
0.00%
0/70
|
12.5%
1/8
|
|
Psychiatric disorders
Depression
|
0.00%
0/70
|
12.5%
1/8
|
|
Psychiatric disorders
Hallucination
|
1.4%
1/70
|
0.00%
0/8
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Oliguria
|
2.9%
2/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal failure
|
2.9%
2/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
2/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Haematuria
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Nocturia
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Pollakiuria
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Pyuria
|
1.4%
1/70
|
0.00%
0/8
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/70
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Penile oedema
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
14/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
10/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
5/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
4/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
4/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
3/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
2/70
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
4.3%
3/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.9%
2/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
2/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.4%
1/70
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal inflammation
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.6%
6/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.1%
5/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
3/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
3/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
3/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
3/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.9%
2/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
2/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
1/70
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.9%
2/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
1.4%
1/70
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.4%
1/70
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
5.7%
4/70
|
12.5%
1/8
|
|
Vascular disorders
Jugular vein distension
|
1.4%
1/70
|
0.00%
0/8
|
|
Vascular disorders
Orthostatic hypotension
|
1.4%
1/70
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place