Trial Outcomes & Findings for Safety of PCI-32765 in Chronic Lymphocytic Leukemia (NCT NCT01105247)
NCT ID: NCT01105247
Last Updated: 2014-03-31
Results Overview
Number of participants who had experienced at least one treatment emergent AEs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
133 participants
Primary outcome timeframe
From first dose to within 30 days of last dose of PCI-32765
Results posted on
2014-03-31
Participant Flow
There are total 133 subjects enrolled however one subject never received treatment. Therefore, number of subjects "Started" the study is listed as 132 subjects.
Participant milestones
| Measure |
PCI-32765
PCI-32765: 420 mg daily or 840 mg daily.
|
Food Effect Cohort
PCI-32765: 420 mg daily
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
16
|
|
Overall Study
COMPLETED
|
79
|
16
|
|
Overall Study
NOT COMPLETED
|
37
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of PCI-32765 in Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
PCI-32765
n=116 Participants
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect Cohort
n=16 Participants
PCI-32765: 420 mg daily
|
Total
n=132 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
|
42 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to within 30 days of last dose of PCI-32765Number of participants who had experienced at least one treatment emergent AEs.
Outcome measures
| Measure |
PCI-32765
n=116 Participants
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect
n=16 Participants
Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
|
Food- Effect
Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
|
116 Participants
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.Population: Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.
Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.
Outcome measures
| Measure |
PCI-32765
n=15 Participants
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect
Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
|
Food- Effect
Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
|
|---|---|---|---|
|
Food Effect Cohort Assessments
|
1.65 (NUMBER)
Interval 1.23 to 2.19
|
—
|
—
|
SECONDARY outcome
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.
Outcome measures
| Measure |
PCI-32765
n=31 Participants
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect
n=85 Participants
Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
|
Food- Effect
n=16 Participants
Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
|
|---|---|---|---|
|
Progression Free Survival Rate at 24 Months
|
96.3 Percentage of Participants
Interval 76.5 to 99.5
|
73.6 Percentage of Participants
Interval 60.2 to 83.1
|
NA Percentage of Participants
There was no PD or death occurred in this arm.
|
SECONDARY outcome
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.
Outcome measures
| Measure |
PCI-32765
n=31 Participants
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect
n=85 Participants
Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
|
Food- Effect
n=16 Participants
Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
|
|---|---|---|---|
|
Percentage of Participants Achieving Response
|
71 Percentage of Participants
Interval 52.0 to 85.8
|
75.3 Percentage of Participants
Interval 64.7 to 84.0
|
56.3 Percentage of Participants
Interval 29.9 to 80.2
|
Adverse Events
PCI-32765
Serious events: 61 serious events
Other events: 116 other events
Deaths: 0 deaths
Food Effect
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCI-32765
n=116 participants at risk
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect
n=16 participants at risk
PCI-32765: 420 mg daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
5/116
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.7%
2/116
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.86%
1/116
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.86%
1/116
|
0.00%
0/16
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
4/116
|
0.00%
0/16
|
|
Cardiac disorders
Angina pectoris
|
0.86%
1/116
|
0.00%
0/16
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.86%
1/116
|
0.00%
0/16
|
|
Eye disorders
Vision blurred
|
0.86%
1/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.86%
1/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.86%
1/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.86%
1/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Ileus
|
0.86%
1/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
0.86%
1/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
1/116
|
0.00%
0/16
|
|
General disorders
Asthenia
|
0.86%
1/116
|
0.00%
0/16
|
|
General disorders
Pyrexia
|
0.86%
1/116
|
0.00%
0/16
|
|
General disorders
Systemic inflammatory response syndrome
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Pneumonia
|
9.5%
11/116
|
25.0%
4/16
|
|
Infections and infestations
Bacteraemia
|
3.4%
4/116
|
0.00%
0/16
|
|
Infections and infestations
Cellulitis
|
3.4%
4/116
|
0.00%
0/16
|
|
Infections and infestations
Sinusitis
|
3.4%
4/116
|
0.00%
0/16
|
|
Infections and infestations
Sepsis
|
2.6%
3/116
|
0.00%
0/16
|
|
Infections and infestations
Clostridial infection
|
1.7%
2/116
|
0.00%
0/16
|
|
Infections and infestations
Pneumonia viral
|
1.7%
2/116
|
0.00%
0/16
|
|
Infections and infestations
Bacterial sepsis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Bronchitis viral
|
0.86%
1/116
|
6.2%
1/16
|
|
Infections and infestations
Chronic sinusitis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Citrobacter infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Clostridium difficile colitis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Cystitis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Device related infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Gastroenteritis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Herpes zoster disseminated
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Joint abscess
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Labyrinthitis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Lobar pneumonia
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Pneumonia influenzal
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Pneumonia streptococcal
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Rhinovirus infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.86%
1/116
|
6.2%
1/16
|
|
Infections and infestations
Upper respiratory tract infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Urinary tract infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Varicella
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Vestibular neuronitis
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Viral Infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.86%
1/116
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.7%
2/116
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Laceration
|
0.86%
1/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.7%
2/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.86%
1/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Dehydration
|
0.86%
1/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.86%
1/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.86%
1/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.86%
1/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.86%
1/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.86%
1/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.86%
1/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Richter's syndrome
|
1.7%
2/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.86%
1/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukostasis
|
0.86%
1/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant histiocytosis
|
0.86%
1/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified
|
0.86%
1/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.86%
1/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.86%
1/116
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
1.7%
2/116
|
0.00%
0/16
|
|
Nervous system disorders
Cerebrovascular accident
|
0.86%
1/116
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
0.86%
1/116
|
0.00%
0/16
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.86%
1/116
|
0.00%
0/16
|
|
Nervous system disorders
Transient ischaemic attack
|
0.86%
1/116
|
0.00%
0/16
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.86%
1/116
|
0.00%
0/16
|
|
Renal and urinary disorders
Urinary retention
|
0.86%
1/116
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.86%
1/116
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.86%
1/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.86%
1/116
|
0.00%
0/16
|
|
Vascular disorders
Hypertension
|
0.86%
1/116
|
0.00%
0/16
|
|
Vascular disorders
Orthostatic hypotension
|
0.86%
1/116
|
0.00%
0/16
|
|
Nervous system disorders
Syncope
|
0.00%
0/116
|
6.2%
1/16
|
Other adverse events
| Measure |
PCI-32765
n=116 participants at risk
PCI-32765: 420 mg daily or 840 mg daily
|
Food Effect
n=16 participants at risk
PCI-32765: 420 mg daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.4%
19/116
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.8%
16/116
|
12.5%
2/16
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.9%
15/116
|
0.00%
0/16
|
|
Eye disorders
Dry eye
|
9.5%
11/116
|
0.00%
0/16
|
|
Eye disorders
Cataract
|
5.2%
6/116
|
0.00%
0/16
|
|
Eye disorders
Conjunctivitis
|
5.2%
6/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Constipation
|
21.6%
25/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Dyspepsia
|
14.7%
17/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
16/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.2%
13/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
7/116
|
0.00%
0/16
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.2%
6/116
|
0.00%
0/16
|
|
General disorders
Fatigue
|
32.8%
38/116
|
25.0%
4/16
|
|
General disorders
Oedema peripheral
|
28.4%
33/116
|
6.2%
1/16
|
|
General disorders
Chills
|
12.1%
14/116
|
18.8%
3/16
|
|
General disorders
Malaise
|
7.8%
9/116
|
6.2%
1/16
|
|
General disorders
Pain
|
5.2%
6/116
|
6.2%
1/16
|
|
Immune system disorders
Allergy to arthropod bite
|
6.0%
7/116
|
0.00%
0/16
|
|
Infections and infestations
Bronchitis
|
7.8%
9/116
|
0.00%
0/16
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
8/116
|
0.00%
0/16
|
|
Infections and infestations
Fungal infection
|
5.2%
6/116
|
6.2%
1/16
|
|
Infections and infestations
Gastroenteritis viral
|
5.2%
6/116
|
0.00%
0/16
|
|
Infections and infestations
Oral herpes
|
5.2%
6/116
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Contusion
|
19.0%
22/116
|
25.0%
4/16
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.9%
8/116
|
12.5%
2/16
|
|
Investigations
Weight decreased
|
6.9%
8/116
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.2%
13/116
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.5%
11/116
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.6%
10/116
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.9%
8/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
31/116
|
31.2%
5/16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
18.1%
21/116
|
18.8%
3/16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.9%
15/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.2%
13/116
|
18.8%
3/16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
8/116
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.2%
6/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
9.5%
11/116
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
5.2%
6/116
|
0.00%
0/16
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.6%
10/116
|
0.00%
0/16
|
|
Psychiatric disorders
Anxiety
|
12.9%
15/116
|
6.2%
1/16
|
|
Psychiatric disorders
Insomnia
|
12.1%
14/116
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
27/116
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.8%
16/116
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.2%
13/116
|
25.0%
4/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
10/116
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.6%
10/116
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.8%
9/116
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.9%
8/116
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.0%
7/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
14.7%
17/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
12.1%
14/116
|
18.8%
3/16
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
9.5%
11/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
10/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.9%
8/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.9%
8/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
8/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.0%
7/116
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.2%
6/116
|
0.00%
0/16
|
|
Vascular disorders
Hypotension
|
6.9%
8/116
|
0.00%
0/16
|
|
Eye disorders
Vision Blurred
|
5.2%
6/116
|
6.2%
1/16
|
|
Eye disorders
Conjuctival hyperaemia
|
0.00%
0/116
|
6.2%
1/16
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Diarrhoea
|
56.0%
65/116
|
68.8%
11/16
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
22/116
|
68.8%
11/16
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/116
|
12.5%
2/16
|
|
Gastrointestinal disorders
Nausea
|
26.7%
31/116
|
12.5%
2/16
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
5/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.6%
3/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/116
|
6.2%
1/16
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.86%
1/116
|
6.2%
1/16
|
|
General disorders
Early satiety
|
2.6%
3/116
|
6.2%
1/16
|
|
General disorders
Injection site haematoma
|
0.00%
0/116
|
6.2%
1/16
|
|
General disorders
Hypogammaglobulinaemia
|
3.4%
4/116
|
6.2%
1/16
|
|
Infections and infestations
Upper respiratory tract infection
|
31.9%
37/116
|
25.0%
4/16
|
|
Infections and infestations
Cellulitis
|
6.0%
7/116
|
6.2%
1/16
|
|
Infections and infestations
Folliculitis
|
4.3%
5/116
|
6.2%
1/16
|
|
Infections and infestations
Furuncle
|
0.00%
0/116
|
6.2%
1/16
|
|
Infections and infestations
Skin infection
|
2.6%
3/116
|
6.2%
1/16
|
|
Infections and infestations
Urinary track infection
|
12.1%
14/116
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Laceration
|
6.0%
7/116
|
12.5%
2/16
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.7%
2/116
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/116
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/116
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Scratch
|
0.86%
1/116
|
6.2%
1/16
|
|
Investigations
Blood urea increased
|
1.7%
2/116
|
6.2%
1/16
|
|
Investigations
Cardiac murmur
|
3.4%
4/116
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
5/116
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/116
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.4%
4/116
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
10/116
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/116
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.6%
3/116
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.86%
1/116
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.7%
2/116
|
6.2%
1/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
6.9%
8/116
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
19.0%
22/116
|
25.0%
4/16
|
|
Psychiatric disorders
Depression
|
3.4%
4/116
|
6.2%
1/16
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
3/116
|
12.5%
2/16
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/116
|
6.2%
1/16
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/116
|
6.2%
1/16
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/116
|
6.2%
1/16
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/116
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.86%
1/116
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
3.4%
4/116
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
1.7%
2/116
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.86%
1/116
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.86%
1/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.00%
0/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Pseudoporphyria
|
0.00%
0/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.3%
5/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.6%
3/116
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/116
|
6.2%
1/16
|
|
Vascular disorders
Hypertension
|
23.3%
27/116
|
12.5%
2/16
|
|
Vascular disorders
Lymphoedema
|
0.86%
1/116
|
6.2%
1/16
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/116
|
6.2%
1/16
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/116
|
6.2%
1/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place