Trial Outcomes & Findings for Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) (NCT NCT01117987)
NCT ID: NCT01117987
Last Updated: 2015-08-13
Results Overview
Adverse event monitoring was conducted throughout the study.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
204 weeks
Results posted on
2015-08-13
Participant Flow
Participant milestones
| Measure |
Core Imatinib
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
78
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
61
|
74
|
Reasons for withdrawal
| Measure |
Core Imatinib
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Overall Study
Protocol deviation
|
0
|
1
|
|
Overall Study
Subject no longer requires study drug
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Abnormal test procedure result
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
|
Overall Study
Death
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
10
|
|
Overall Study
Adverse Event
|
19
|
26
|
|
Overall Study
Administrative problems
|
25
|
22
|
Baseline Characteristics
Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Baseline characteristics by cohort
| Measure |
Core Imatinib
n=66 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
n=78 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 15.52 • n=5 Participants
|
45.7 Years
STANDARD_DEVIATION 13.31 • n=7 Participants
|
47.4 Years
STANDARD_DEVIATION 14.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 204 weeksPopulation: Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.
Adverse event monitoring was conducted throughout the study.
Outcome measures
| Measure |
Core Imatinib
n=66 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
n=78 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Adverse events (non-serious and serious)
|
62 Participants
|
76 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Serious adverse events
|
40 Participants
|
53 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Deaths
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeksPopulation: Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.
A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).
Outcome measures
| Measure |
Core Imatinib
n=66 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
n=78 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Extension baseline (n=61,77)
|
42.98 meters
Standard Deviation 55.209
|
4.91 meters
Standard Deviation 62.629
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 12 (n=58,57)
|
48.75 meters
Standard Deviation 60.887
|
16.25 meters
Standard Deviation 64.992
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 24 (n=54,53)
|
44.71 meters
Standard Deviation 45.506
|
19.34 meters
Standard Deviation 71.675
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 48 (n=47,42)
|
45.81 meters
Standard Deviation 72.150
|
29.18 meters
Standard Deviation 65.198
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 72 (n=40,39)
|
49.54 meters
Standard Deviation 76.019
|
56.46 meters
Standard Deviation 111.130
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 96 (n=38,35)
|
66.64 meters
Standard Deviation 71.080
|
41.03 meters
Standard Deviation 54.495
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 120 (n=32,29)
|
83.19 meters
Standard Deviation 67.855
|
37.43 meters
Standard Deviation 60.087
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 144 (n=27,21)
|
67.70 meters
Standard Deviation 64.000
|
39.45 meters
Standard Deviation 79.356
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 156 (n=21,18)
|
72.60 meters
Standard Deviation 67.972
|
30.17 meters
Standard Deviation 66.856
|
|
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Week 204 (n=4,3)
|
96.88 meters
Standard Deviation 42.048
|
4.50 meters
Standard Deviation 25.608
|
SECONDARY outcome
Timeframe: 204 weeksPopulation: Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.
Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO \& 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.
Outcome measures
| Measure |
Core Imatinib
n=66 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
n=78 Participants
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Percentage of Participants With Incidence of Clinical Worsening Events
Total participants with clinical worsening
|
50.0 Percentage of participants
|
46.2 Percentage of participants
|
|
Percentage of Participants With Incidence of Clinical Worsening Events
Death (all deaths)
|
7.6 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants With Incidence of Clinical Worsening Events
Hospitalization for worsening of PAH
|
33.3 Percentage of participants
|
28.2 Percentage of participants
|
|
Percentage of Participants With Incidence of Clinical Worsening Events
Drop in WHO
|
24.2 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants With Incidence of Clinical Worsening Events
6MWD reduction
|
12.1 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants With Incidence of Clinical Worsening Events
Drop in WHO and 6MWD reduction
|
1.5 Percentage of participants
|
3.8 Percentage of participants
|
Adverse Events
Core Imatinib
Serious events: 40 serious events
Other events: 55 other events
Deaths: 0 deaths
Core Placebo
Serious events: 53 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core Imatinib
n=66 participants at risk
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
n=78 participants at risk
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/66
|
1.3%
1/78
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
3/66
|
2.6%
2/78
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.0%
2/66
|
0.00%
0/78
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/66
|
1.3%
1/78
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.5%
1/66
|
0.00%
0/78
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/66
|
3.8%
3/78
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/66
|
1.3%
1/78
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/66
|
0.00%
0/78
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Atrial flutter
|
1.5%
1/66
|
1.3%
1/78
|
|
Cardiac disorders
Atrial tachycardia
|
1.5%
1/66
|
0.00%
0/78
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/66
|
2.6%
2/78
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/66
|
1.3%
1/78
|
|
Cardiac disorders
Myocardial ischaemia
|
1.5%
1/66
|
0.00%
0/78
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/66
|
0.00%
0/78
|
|
Cardiac disorders
Right ventricular failure
|
7.6%
5/66
|
10.3%
8/78
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/66
|
0.00%
0/78
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/66
|
1.3%
1/78
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/66
|
1.3%
1/78
|
|
Endocrine disorders
Hyperthyroidism
|
1.5%
1/66
|
1.3%
1/78
|
|
Eye disorders
Astigmatism
|
1.5%
1/66
|
0.00%
0/78
|
|
Eye disorders
Cataract
|
1.5%
1/66
|
0.00%
0/78
|
|
Eye disorders
Corneal erosion
|
1.5%
1/66
|
0.00%
0/78
|
|
Eye disorders
Glaucoma
|
1.5%
1/66
|
0.00%
0/78
|
|
Eye disorders
Periorbital oedema
|
1.5%
1/66
|
1.3%
1/78
|
|
Gastrointestinal disorders
Abdominal adhesions
|
1.5%
1/66
|
0.00%
0/78
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/66
|
1.3%
1/78
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/66
|
0.00%
0/78
|
|
Gastrointestinal disorders
Colonic fistula
|
1.5%
1/66
|
0.00%
0/78
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
2/66
|
0.00%
0/78
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/66
|
1.3%
1/78
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/66
|
1.3%
1/78
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/66
|
1.3%
1/78
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/66
|
1.3%
1/78
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66
|
3.8%
3/78
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.5%
1/66
|
0.00%
0/78
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
1/66
|
0.00%
0/78
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/66
|
2.6%
2/78
|
|
General disorders
Asthenia
|
1.5%
1/66
|
0.00%
0/78
|
|
General disorders
Brain death
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Chest pain
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Chills
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Device dislocation
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Device leakage
|
1.5%
1/66
|
0.00%
0/78
|
|
General disorders
Device malfunction
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Device occlusion
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/66
|
1.3%
1/78
|
|
General disorders
Medical device complication
|
1.5%
1/66
|
0.00%
0/78
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/66
|
1.3%
1/78
|
|
General disorders
Oedema peripheral
|
1.5%
1/66
|
0.00%
0/78
|
|
General disorders
Pyrexia
|
1.5%
1/66
|
3.8%
3/78
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/66
|
2.6%
2/78
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/66
|
1.3%
1/78
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Cellulitis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Colonic abscess
|
1.5%
1/66
|
0.00%
0/78
|
|
Infections and infestations
Device related infection
|
7.6%
5/66
|
3.8%
3/78
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Diverticulitis
|
1.5%
1/66
|
0.00%
0/78
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/66
|
0.00%
0/78
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Influenza
|
1.5%
1/66
|
1.3%
1/78
|
|
Infections and infestations
Lobar pneumonia
|
1.5%
1/66
|
0.00%
0/78
|
|
Infections and infestations
Mastitis
|
1.5%
1/66
|
0.00%
0/78
|
|
Infections and infestations
Mycobacterial infection
|
1.5%
1/66
|
0.00%
0/78
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Pneumonia
|
4.5%
3/66
|
3.8%
3/78
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/66
|
1.3%
1/78
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66
|
1.3%
1/78
|
|
Infections and infestations
Viral infection
|
0.00%
0/66
|
1.3%
1/78
|
|
Injury, poisoning and procedural complications
Bone contusion
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Complications of transplanted lung
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/66
|
1.3%
1/78
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.5%
1/66
|
3.8%
3/78
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.5%
1/66
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/66
|
1.3%
1/78
|
|
Investigations
Blood potassium increased
|
1.5%
1/66
|
0.00%
0/78
|
|
Investigations
Eosinophil percentage increased
|
0.00%
0/66
|
1.3%
1/78
|
|
Investigations
Haematocrit decreased
|
0.00%
0/66
|
1.3%
1/78
|
|
Investigations
Intraocular pressure increased
|
1.5%
1/66
|
0.00%
0/78
|
|
Investigations
N-terminal prohormone brain natriuretic peptide
|
1.5%
1/66
|
0.00%
0/78
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/66
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66
|
3.8%
3/78
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.5%
1/66
|
0.00%
0/78
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/66
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/66
|
2.6%
2/78
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/66
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/66
|
0.00%
0/78
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/66
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/66
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.5%
1/66
|
0.00%
0/78
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.5%
1/66
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.5%
1/66
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/66
|
1.3%
1/78
|
|
Musculoskeletal and connective tissue disorders
Systemic sclerosis
|
0.00%
0/66
|
1.3%
1/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.5%
1/66
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/66
|
1.3%
1/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/66
|
1.3%
1/78
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.5%
1/66
|
1.3%
1/78
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
1/66
|
0.00%
0/78
|
|
Nervous system disorders
Convulsion
|
1.5%
1/66
|
1.3%
1/78
|
|
Nervous system disorders
Presyncope
|
1.5%
1/66
|
2.6%
2/78
|
|
Nervous system disorders
Syncope
|
3.0%
2/66
|
9.0%
7/78
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/66
|
0.00%
0/78
|
|
Psychiatric disorders
Bipolar disorder
|
1.5%
1/66
|
0.00%
0/78
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/66
|
1.3%
1/78
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/66
|
1.3%
1/78
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/66
|
1.3%
1/78
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/66
|
1.3%
1/78
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/66
|
2.6%
2/78
|
|
Renal and urinary disorders
Renal failure acute
|
3.0%
2/66
|
2.6%
2/78
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/66
|
1.3%
1/78
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
1.5%
1/66
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
1.5%
1/66
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
4/66
|
6.4%
5/78
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.5%
3/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/66
|
2.6%
2/78
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
9.1%
6/66
|
10.3%
8/78
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/66
|
2.6%
2/78
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.5%
1/66
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
3/66
|
2.6%
2/78
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/66
|
2.6%
2/78
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/66
|
1.3%
1/78
|
|
Skin and subcutaneous tissue disorders
Scleroedema
|
1.5%
1/66
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/66
|
1.3%
1/78
|
|
Surgical and medical procedures
Craniotomy
|
0.00%
0/66
|
1.3%
1/78
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/66
|
1.3%
1/78
|
|
Vascular disorders
Haematoma
|
1.5%
1/66
|
1.3%
1/78
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/66
|
1.3%
1/78
|
|
Vascular disorders
Hypotension
|
3.0%
2/66
|
1.3%
1/78
|
|
Vascular disorders
Thrombosis
|
0.00%
0/66
|
1.3%
1/78
|
Other adverse events
| Measure |
Core Imatinib
n=66 participants at risk
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
Core Placebo
n=78 participants at risk
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.6%
5/66
|
10.3%
8/78
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.6%
5/66
|
7.7%
6/78
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.5%
1/66
|
11.5%
9/78
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
6/66
|
9.0%
7/78
|
|
Cardiac disorders
Palpitations
|
6.1%
4/66
|
5.1%
4/78
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/66
|
5.1%
4/78
|
|
Cardiac disorders
Tachycardia
|
6.1%
4/66
|
5.1%
4/78
|
|
Eye disorders
Conjunctival haemorrhage
|
3.0%
2/66
|
6.4%
5/78
|
|
Eye disorders
Periorbital oedema
|
16.7%
11/66
|
29.5%
23/78
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.0%
2/66
|
6.4%
5/78
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
4/66
|
3.8%
3/78
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
6/66
|
6.4%
5/78
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
2/66
|
6.4%
5/78
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/66
|
6.4%
5/78
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
18/66
|
34.6%
27/78
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
3/66
|
5.1%
4/78
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/66
|
5.1%
4/78
|
|
Gastrointestinal disorders
Nausea
|
31.8%
21/66
|
50.0%
39/78
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
14/66
|
32.1%
25/78
|
|
General disorders
Asthenia
|
6.1%
4/66
|
2.6%
2/78
|
|
General disorders
Chest discomfort
|
3.0%
2/66
|
5.1%
4/78
|
|
General disorders
Face oedema
|
1.5%
1/66
|
5.1%
4/78
|
|
General disorders
Fatigue
|
13.6%
9/66
|
14.1%
11/78
|
|
General disorders
Non-cardiac chest pain
|
6.1%
4/66
|
5.1%
4/78
|
|
General disorders
Oedema peripheral
|
31.8%
21/66
|
41.0%
32/78
|
|
General disorders
Pyrexia
|
13.6%
9/66
|
6.4%
5/78
|
|
Immune system disorders
Seasonal allergy
|
4.5%
3/66
|
5.1%
4/78
|
|
Infections and infestations
Bronchitis
|
1.5%
1/66
|
10.3%
8/78
|
|
Infections and infestations
Device related infection
|
0.00%
0/66
|
5.1%
4/78
|
|
Infections and infestations
Influenza
|
7.6%
5/66
|
2.6%
2/78
|
|
Infections and infestations
Nasopharyngitis
|
25.8%
17/66
|
30.8%
24/78
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66
|
5.1%
4/78
|
|
Infections and infestations
Respiratory tract infection
|
4.5%
3/66
|
9.0%
7/78
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
6/66
|
14.1%
11/78
|
|
Infections and infestations
Urinary tract infection
|
4.5%
3/66
|
10.3%
8/78
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
4/66
|
1.3%
1/78
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
4/66
|
1.3%
1/78
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/66
|
5.1%
4/78
|
|
Investigations
Blood creatinine increased
|
6.1%
4/66
|
3.8%
3/78
|
|
Investigations
Weight decreased
|
7.6%
5/66
|
3.8%
3/78
|
|
Investigations
Weight increased
|
6.1%
4/66
|
5.1%
4/78
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
2/66
|
5.1%
4/78
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.5%
1/66
|
5.1%
4/78
|
|
Metabolism and nutrition disorders
Gout
|
3.0%
2/66
|
5.1%
4/78
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.6%
5/66
|
12.8%
10/78
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
7.6%
5/66
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
5/66
|
15.4%
12/78
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
6/66
|
5.1%
4/78
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.1%
8/66
|
15.4%
12/78
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
4/66
|
2.6%
2/78
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
2/66
|
5.1%
4/78
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
6/66
|
6.4%
5/78
|
|
Nervous system disorders
Dizziness
|
13.6%
9/66
|
6.4%
5/78
|
|
Nervous system disorders
Headache
|
18.2%
12/66
|
30.8%
24/78
|
|
Psychiatric disorders
Insomnia
|
3.0%
2/66
|
6.4%
5/78
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.2%
16/66
|
14.1%
11/78
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
10/66
|
7.7%
6/78
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
6/66
|
7.7%
6/78
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
2/66
|
5.1%
4/78
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.6%
5/66
|
2.6%
2/78
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.1%
8/66
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
3.0%
2/66
|
5.1%
4/78
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
3/66
|
5.1%
4/78
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/66
|
7.7%
6/78
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.6%
7/66
|
16.7%
13/78
|
|
Vascular disorders
Flushing
|
3.0%
2/66
|
6.4%
5/78
|
|
Vascular disorders
Hypotension
|
9.1%
6/66
|
3.8%
3/78
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER