Trial Outcomes & Findings for Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (NCT NCT01236391)
NCT ID: NCT01236391
Last Updated: 2015-08-28
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. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a \>/= 50% decrease in the sum of the product of diameters of the target lesions, and \>/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months
Results posted on
2015-08-28
Participant Flow
One hundred fifteen subjects were enrolled and 111 subjects received at least 1 dose of ibrutinib and constitute the all treated population and the safety analysis set.
Participant milestones
| Measure |
PCI-32765
Participants received 560 mg daily
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
95
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Baseline characteristics by cohort
| Measure |
PCI-32765
n=111 Participants
PCI-32765: 560 mg daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
70 Participants
n=93 Participants
|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) monthsPopulation: Participants who received at least 1 dose of PCI-32765 and constitute the all treated population
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. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a \>/= 50% decrease in the sum of the product of diameters of the target lesions, and \>/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.
Outcome measures
| Measure |
PCI-32765
n=111 Participants
PCI-32765: 560 mg daily
|
PCI-45227 (Metabolite)- Day 8
PCI-32765: 560 mg daily
|
|---|---|---|
|
Percentage of Participants Achieving Response
|
67.6 percentage of participants with response
Interval 58.9 to 76.3
|
—
|
SECONDARY outcome
Timeframe: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closureNumber of participants who had experienced at least one treatment emergent AE
Outcome measures
| Measure |
PCI-32765
n=111 Participants
PCI-32765: 560 mg daily
|
PCI-45227 (Metabolite)- Day 8
PCI-32765: 560 mg daily
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
|
111 participants
|
—
|
SECONDARY outcome
Timeframe: Performed During the First Month of Receiving PCI-32765Population: PK samples were collected in a subset of participants (n=48) in this trial (n=111). PK parameters reported here reflects those that were PK evaluable from the 48 participants.
Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)
Outcome measures
| Measure |
PCI-32765
n=43 Participants
PCI-32765: 560 mg daily
|
PCI-45227 (Metabolite)- Day 8
n=44 Participants
PCI-32765: 560 mg daily
|
|---|---|---|
|
PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765
|
953 AUC0-24h (ng*h/mL)
Standard Deviation 705
|
1263 AUC0-24h (ng*h/mL)
Standard Deviation 707
|
SECONDARY outcome
Timeframe: From Baseline to Cycle 5 (Week 20)Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.
Outcome measures
| Measure |
PCI-32765
n=69 Participants
PCI-32765: 560 mg daily
|
PCI-45227 (Metabolite)- Day 8
PCI-32765: 560 mg daily
|
|---|---|---|
|
Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score
|
0.6 scores on a scale
Standard Deviation 22.4
|
—
|
Adverse Events
PCI-32765
Serious events: 62 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCI-32765
n=111 participants at risk
PCI-32765: 560 mg daily
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Atrial flutter
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Cardiac arrest
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Cardiac failure
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Coronary artery occlusion
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Ileus
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Oedema peripheral
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Pyrexia
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Non-cardiac chest pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Chills
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Device leakage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
General physical health deterioration
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Urinary tract infection
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bronchitis
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cellulitis
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Sepsis
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Anal abscess
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cellulitis orbital
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Clostridium difficile colitis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Enterocolitis infectious
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Gastroenteritis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lower respiratory tract infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia bacterial
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia klebsiella
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Respiratory tract infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Streptococcal infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Wound infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Headache
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Transient global amnesia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Confusional state
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Renal failure acute
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Haematuria
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Renal failure
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Hypotension
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
Other adverse events
| Measure |
PCI-32765
n=111 participants at risk
PCI-32765: 560 mg daily
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
18.0%
20/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.0%
20/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Anaemia
|
12.6%
14/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.3%
7/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Atrial fibrillation
|
6.3%
7/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Sinus bradycardia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Cardiac failure
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Mitral valve incompetence
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Myocardial infarction
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Palpitations
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Torsade de pointes
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Cardiac disorders
Ventricular tachycardia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Ear and labyrinth disorders
Ear pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Ear and labyrinth disorders
Tinnitus
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Ear and labyrinth disorders
Vertigo
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Lacrimation increased
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Cataract
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Conjunctivitis
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Dry eye
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Ocular hyperaemia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Vision blurred
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Visual acuity reduced
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Vitreous floaters
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Conjunctival haemorrhage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Diabetic retinopathy
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Eye inflammation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Eyelid ptosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Periorbital oedema
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Photophobia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Retinal detachment
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Eye disorders
Scleral haemorrhage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
49.5%
55/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Nausea
|
30.6%
34/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Constipation
|
25.2%
28/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
25/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
15.3%
17/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Stomatitis
|
11.7%
13/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
10.8%
12/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gastritis
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal distension
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Oral pain
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Epigastric discomfort
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gingival oedema
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Proctalgia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Tongue ulceration
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Cheilitis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Eructation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Glossodynia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Haematochezia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Lip blister
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Lip swelling
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Lip ulceration
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Odynophagia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Palatal disorder
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Periodontal disease
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Proctitis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Rectal fissure
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Fatigue
|
41.4%
46/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Oedema peripheral
|
27.0%
30/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Pyrexia
|
16.2%
18/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Asthenia
|
10.8%
12/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Influenza like illness
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Chills
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Chest pain
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Mucosal inflammation
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Non-cardiac chest pain
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Pain
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Local swelling
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Axillary pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Chest discomfort
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Crepitations
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Device leakage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Feeling abnormal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Generalised oedema
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Gravitational oedema
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Induration
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Injection site erythema
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Injection site extravasation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Injection site haematoma
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Injection site pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Injection site reaction
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Malaise
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Oedema
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Performance status decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
General disorders
Xerosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Immune system disorders
Seasonal allergy
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Immune system disorders
Hypersensitivity
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Immune system disorders
Allergy to arthropod bite
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Immune system disorders
Drug hypersensitivity
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
23.4%
26/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Sinusitis
|
12.6%
14/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Urinary tract infection
|
12.6%
14/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia
|
9.0%
10/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
9/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bronchitis
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cellulitis
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Folliculitis
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Herpes zoster
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Rhinitis
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Oral herpes
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Skin infection
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Clostridium difficile colitis
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Gastroenteritis
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lower respiratory tract infection
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Paronychia
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Staphylococcal infection
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Tooth infection
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bacteraemia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Clostridial infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Diverticulitis
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Eye infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Herpes simplex
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Localised infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Otitis media
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Viral infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Wound infection
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Bronchiolitis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Citrobacter infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Conjunctivitis infective
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Cryptococcosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Eye infection bacterial
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Gastroenteritis viral
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Genital infection fungal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Haemophilus infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Herpes virus infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Histoplasmosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Implant site infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Incision site infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Influenza
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Klebsiella infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lip infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Nail infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Onychomycosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Oral candidiasis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Papilloma viral infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Pneumonia bacterial
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Rash pustular
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Rectal abscess
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Streptococcal infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Tinea pedis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
17.1%
19/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Fall
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Laceration
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Head injury
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Open wound
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Injury, poisoning and procedural complications
Wound
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood creatinine increased
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Weight decreased
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Weight increased
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood bilirubin increased
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Cardiac murmur
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Glomerular filtration rate decreased
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
International normalised ratio increased
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Aspergillus test positive
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood alkaline phosphatase increased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood bilirubin abnormal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood cholesterol increased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood immunoglobulin G decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood iron decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Blood phosphorus decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Breath sounds abnormal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
C-reactive protein increased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Haemophilus test positive
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Heart rate irregular
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Liver function test abnormal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Macular reflex abnormal
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Mean cell volume increased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Platelet count decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
Urine output decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Investigations
White blood cell count increased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.6%
24/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
13.5%
15/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
10.8%
12/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
9/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Enzyme abnormality
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Gout
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.4%
16/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
14/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.6%
14/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.8%
12/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
11/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Dizziness
|
14.4%
16/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Headache
|
10.8%
12/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Paraesthesia
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Memory impairment
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Amnesia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Lethargy
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Somnolence
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Balance disorder
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Dizziness postural
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Head discomfort
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Hypersomnia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Hypoaesthesia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Migraine
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Migraine with aura
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Neuralgia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Neuropathy peripheral
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Nystagmus
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Presyncope
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Sciatica
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Sensory disturbance
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Tension headache
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Nervous system disorders
Tremor
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Insomnia
|
9.9%
11/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Anxiety
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Depression
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Agitation
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Confusional state
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Abnormal behaviour
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Euphoric mood
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Libido decreased
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Mania
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Psychiatric disorders
Panic attack
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Haematuria
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Renal failure acute
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Pollakiuria
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Dysuria
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Renal impairment
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Azotaemia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Hydronephrosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Micturition urgency
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Nocturia
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Renal and urinary disorders
Urinary tract pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Haematospermia
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Oedema genital
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Breast pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Penile pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.1%
29/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
20/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.8%
12/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.0%
10/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.3%
17/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.0%
10/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.2%
8/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.5%
5/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.6%
4/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.7%
3/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Hypertension
|
9.9%
11/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Hypotension
|
5.4%
6/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Orthostatic hypotension
|
1.8%
2/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Blood pressure fluctuation
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Flushing
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
|
Vascular disorders
Varicose vein
|
0.90%
1/111 • From first dose of PCI-32765 to within 30 days of last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place