Trial Outcomes & Findings for Imatinib (QTI571) in Pulmonary Arterial Hypertension (NCT NCT00902174)
NCT ID: NCT00902174
Last Updated: 2016-02-17
Results Overview
This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
24 weeks
Results posted on
2016-02-17
Participant Flow
Overall, 326 participants were screened, 202 participants were randomized (103 to Imatinib and 99 to placebo). Out of 202 participants randomized 201 participants received study drug treatment (103 received imatinib mesylate, 98 received placebo). One participant was randomized to the placebo group but did not receive any study treatment.
Participants were randomized in a 1:1 ratio to imatinib mesylate or placebo.
Participant milestones
| Measure |
Imatinib Mesylate
Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
|
Placebo
Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
99
|
|
Overall Study
COMPLETED
|
69
|
81
|
|
Overall Study
NOT COMPLETED
|
34
|
18
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate
Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
|
Placebo
Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
|
|---|---|---|
|
Overall Study
Adverse Event
|
27
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
5
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Abnormal labs
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Administration problem
|
0
|
1
|
Baseline Characteristics
Imatinib (QTI571) in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate
n=103 Participants
Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
|
Placebo
n=99 Participants
Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 15.33 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 13.60 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 14.59 • n=5 Participants
|
|
Gender
Female
|
83 participants
n=5 Participants
|
79 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Gender
Male
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The Full Analysis Set includes all participants who received at least one dose of study drug and completed the 6MWD Six-minute walk test at week 24. Repeated measurement model was used for this analysis.
This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.
Outcome measures
| Measure |
Imatinib
n=92 Participants
imatinib mesylate
|
Placebo
n=93 Participants
Placebo to imatinib
|
|---|---|---|
|
Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks
|
382.94 meters
Standard Error 9.790
|
351.18 meters
Standard Error 9.834
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The Full Analysis Set included all participants who received at least one dose of study drug and experienced an adjudicated event. A cox regression analysis model was used.
Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.
Outcome measures
| Measure |
Imatinib
n=37 Participants
imatinib mesylate
|
Placebo
n=32 Participants
Placebo to imatinib
|
|---|---|---|
|
Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases
|
35.9 percentage of participants
|
32.7 percentage of participants
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.
Outcome measures
| Measure |
Imatinib
n=73 Participants
imatinib mesylate
|
Placebo
n=81 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Right Atrial Pressure
|
-1.02 mm Hg
Standard Error 0.851
|
0.68 mm Hg
Standard Error 0.855
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis
Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.
Outcome measures
| Measure |
Imatinib
n=75 Participants
imatinib mesylate
|
Placebo
n=82 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Mean Pulmonary Arterial Pressure
|
-3.54 mm Hg
Standard Error 1.585
|
1.63 mm Hg
Standard Error 1.586
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.
Outcome measures
| Measure |
Imatinib
n=74 Participants
imatinib mesylate
|
Placebo
n=80 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Mean Pulmonary Capillary Wedge Pressure
|
0.92 mm Hg
Standard Error 0.693
|
-0.05 mm Hg
Standard Error 0.701
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in systemic vascular resistance (dynes\*sec\*cm\^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.
Outcome measures
| Measure |
Imatinib
n=71 Participants
imatinib mesylate
|
Placebo
n=76 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Systemic Vascular Resistance
|
-467.84 dynes*sec*cm^-5
Standard Error 78.577
|
-88.10 dynes*sec*cm^-5
Standard Error 77.183
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in pulmonary vascular resistance (dynes\*sec\*cm\^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.
Outcome measures
| Measure |
Imatinib
n=74 Participants
imatinib mesylate
|
Placebo
n=80 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Pulmonary Vascular Resistance
|
-366.47 dynes*sec*cm^-5
Standard Error 67.673
|
12.12 dynes*sec*cm^-5
Standard Error 68.963
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in pulmonary resistance index (dynes\*sec\*cm\^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.
Outcome measures
| Measure |
Imatinib
n=74 Participants
imatinib mesylate
|
Placebo
n=80 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Pulmonary Resistance Index
|
-221.29 dynes*sec*cm^-5/m2
Standard Error 47.355
|
21.92 dynes*sec*cm^-5/m2
Standard Error 48.247
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.
Outcome measures
| Measure |
Imatinib
n=75 Participants
imatinib mesylate
|
Placebo
n=81 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Cardiac Output
|
1.17 Liters/minute
Standard Error 0.182
|
0.29 Liters/minute
Standard Error 0.186
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.
Outcome measures
| Measure |
Imatinib
n=73 Participants
imatinib mesylate
|
Placebo
n=78 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Systolic Arterial Blood Pressure
|
-2.92 mm Hg
Standard Error 2.298
|
-1.15 mm Hg
Standard Error 2.227
|
SECONDARY outcome
Timeframe: baseline and week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.
Outcome measures
| Measure |
Imatinib
n=72 Participants
imatinib mesylate
|
Placebo
n=78 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Diastolic Arterial Blood Pressure
|
-3.81 mm Hg
Standard Error 1.958
|
-1.48 mm Hg
Standard Error 1.909
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.
Outcome measures
| Measure |
Imatinib
n=73 Participants
imatinib mesylate
|
Placebo
n=77 Participants
Placebo to imatinib
|
|---|---|---|
|
Change From Baseline in Heart Rate
|
0.38 bpm
Standard Error 12.63
|
0.73 bpm
Standard Error 2.255
|
SECONDARY outcome
Timeframe: week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.
Outcome measures
| Measure |
Imatinib
n=92 Participants
imatinib mesylate
|
Placebo
n=91 Participants
Placebo to imatinib
|
|---|---|---|
|
Change in Borg Dyspnea Score During 6-minute Walk Test
Resting (n= 86 imatinib; 89 placebo)
|
-0.06 units on a scale
Standard Deviation 1.097
|
-0.12 units on a scale
Standard Deviation 1.142
|
|
Change in Borg Dyspnea Score During 6-minute Walk Test
End of test (n= 92 imatinib; 91 placebo)
|
-0.38 units on a scale
Standard Deviation 2.009
|
-0.24 units on a scale
Standard Deviation 2.093
|
|
Change in Borg Dyspnea Score During 6-minute Walk Test
2 min after end (n= 82 imatinib; 81 placebo)
|
-0.37 units on a scale
Standard Deviation 1.409
|
-0.18 units on a scale
Standard Deviation 1.550
|
|
Change in Borg Dyspnea Score During 6-minute Walk Test
End of test - Resting (n= 81 imatinib; 81 placebo)
|
-0.24 units on a scale
Standard Deviation 1.193
|
-0.29 units on a scale
Standard Deviation 1.279
|
|
Change in Borg Dyspnea Score During 6-minute Walk Test
2 min after end - end of test (n= 82 ima; 81plb)
|
-0.07 units on a scale
Standard Deviation 1.533
|
-0.03 units on a scale
Standard Deviation 1.743
|
SECONDARY outcome
Timeframe: Week 24Population: Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.
Outcome measures
| Measure |
Imatinib
n=45 Participants
imatinib mesylate
|
Placebo
n=44 Participants
Placebo to imatinib
|
|---|---|---|
|
Covariance of End of Study CAMPHOR Score
Symptoms score
|
7.93 units on a scale
Standard Error 1.372
|
9.03 units on a scale
Standard Error 1.431
|
|
Covariance of End of Study CAMPHOR Score
Activity score
|
8.99 units on a scale
Standard Error 1.177
|
10.55 units on a scale
Standard Error 1.223
|
|
Covariance of End of Study CAMPHOR Score
Quality of life score
|
7.45 units on a scale
Standard Error 1.026
|
7.13 units on a scale
Standard Error 1.066
|
SECONDARY outcome
Timeframe: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168Population: The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.
Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168. The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay.
Outcome measures
| Measure |
Imatinib
n=77 Participants
imatinib mesylate
|
Placebo
n=77 Participants
Placebo to imatinib
|
|---|---|---|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 1 - predose (n=77 imat; n=77 GCP)
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 1 - 0-3h post-dose (n=77 imat; n=77 GCP)
|
471.9 ng/mL
Standard Deviation 560.1
|
61.8 ng/mL
Standard Deviation 77.6
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 14 - predose (n=18 imat; n=18 GCP)
|
579.6 ng/mL
Standard Deviation 384.9
|
178.8 ng/mL
Standard Deviation 122.8
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 14 - 0-3h post-dose (n=19 imat; n=19 GCP)
|
1005.7 ng/mL
Standard Deviation 665.6
|
233.8 ng/mL
Standard Deviation 170.9
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 28 - predose (n=20 imat; n=20 GCP)
|
658.8 ng/mL
Standard Deviation 450.3
|
228.6 ng/mL
Standard Deviation 121.4
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 28 - 0-3h post-dose (n=19 imat; n=19 GCP)
|
1438.6 ng/mL
Standard Deviation 924.4
|
323.9 ng/mL
Standard Deviation 150.6
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 168 predose (n=24 imat; n=24 GCP)
|
398.6 ng/mL
Standard Deviation 415.5
|
126.6 ng/mL
Standard Deviation 83.3
|
|
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 168- 0-3h post-dose (n=23 imat; n=23 GCP)
|
710.8 ng/mL
Standard Deviation 639.7
|
166.1 ng/mL
Standard Deviation 103.1
|
SECONDARY outcome
Timeframe: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168Population: The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.
Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168. The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay.
Outcome measures
| Measure |
Imatinib
n=62 Participants
imatinib mesylate
|
Placebo
n=62 Participants
Placebo to imatinib
|
|---|---|---|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 1 - predose (n=12 imat; n=12 GCP)
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 1 - 0-3h post-dose (n=13 imat; n=13 GCP)
|
843.2 ng/mL
Standard Deviation 788.9
|
109.9 ng/mL
Standard Deviation 132.4
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 14 - predose (n=62 imat; n=62 GCP)
|
516.5 ng/mL
Standard Deviation 405.2
|
155.1 ng/mL
Standard Deviation 101.1
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 14 - 0-3h post-dose (n=62 imat; n=62 GCP)
|
1172.8 ng/mL
Standard Deviation 1088.9
|
233.7 ng/mL
Standard Deviation 165.6
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 28 - predose (n=55 imat; n=55 GCP)
|
829.8 ng/mL
Standard Deviation 482.6
|
248.2 ng/mL
Standard Deviation 125.2
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 28 - 0-3h post-dose (n=58 imat; n=58 GCP)
|
1335.3 ng/mL
Standard Deviation 817.9
|
320.7 ng/mL
Standard Deviation 154.8
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 168 predose (n=36 imat; n=36 GCP)
|
869.9 ng/mL
Standard Deviation 407.8
|
241.4 ng/mL
Standard Deviation 91.9
|
|
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Day 168- 0-3h post-dose (n=35 imat; n=35 GCP)
|
1616.1 ng/mL
Standard Deviation 787.6
|
348.0 ng/mL
Standard Deviation 119.1
|
Adverse Events
Imatinib
Serious events: 45 serious events
Other events: 96 other events
Deaths: 0 deaths
Placebo
Serious events: 29 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib
n=103 participants at risk
imatinib mesylate
|
Placebo
n=98 participants at risk
Placebo to imatinib
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
7/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Angina pectoris
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Atrial flutter
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Cardiac failure
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Nodal arrhythmia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Right ventricular failure
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Eye disorders
Periorbital oedema
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Eye disorders
Retinal detachment
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
3/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Gastritis
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Melaena
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Catheter site haemorrhage
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Device leakage
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Face oedema
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Fatigue
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Injection site extravasation
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Medical device complication
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Oedema peripheral
|
5.8%
6/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Pyrexia
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Hepatobiliary disorders
Jaundice
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Bacteraemia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Device related infection
|
2.9%
3/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Infection
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Lung infection
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Pneumonia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Pyelonephritis acute
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Sepsis
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Investigations
Cardiac output decreased
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Investigations
International normalised ratio increased
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Investigations
Right atrial pressure increased
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Nervous system disorders
Dizziness
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Nervous system disorders
Headache
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Nervous system disorders
Presyncope
|
4.9%
5/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Nervous system disorders
Syncope
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Renal and urinary disorders
Renal failure
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Renal and urinary disorders
Renal failure acute
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Renal and urinary disorders
Renal impairment
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.8%
6/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
3.9%
4/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
4.1%
4/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
4.1%
4/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary veno-occlusive disease
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Vascular disorders
Haematoma
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Vascular disorders
Hypertension
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Vascular disorders
Hypoperfusion
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
0.00%
0/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
Other adverse events
| Measure |
Imatinib
n=103 participants at risk
imatinib mesylate
|
Placebo
n=98 participants at risk
Placebo to imatinib
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
8/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Cardiac disorders
Palpitations
|
3.9%
4/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
7.1%
7/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Eye disorders
Periorbital oedema
|
29.1%
30/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
7.1%
7/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
8.7%
9/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
3.1%
3/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
6/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
3.1%
3/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
6.1%
6/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
32.0%
33/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
18.4%
18/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
8/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Nausea
|
54.4%
56/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
23.5%
23/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Gastrointestinal disorders
Vomiting
|
29.1%
30/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
10.2%
10/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Face oedema
|
8.7%
9/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Fatigue
|
9.7%
10/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
7.1%
7/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Non-cardiac chest pain
|
2.9%
3/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Oedema peripheral
|
39.8%
41/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
20.4%
20/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
General disorders
Pyrexia
|
6.8%
7/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
3.1%
3/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Device related infection
|
0.97%
1/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Influenza
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Nasopharyngitis
|
17.5%
18/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
19.4%
19/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
3/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
7.1%
7/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Sinusitis
|
1.9%
2/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
6.1%
6/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
5/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
7.1%
7/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Infections and infestations
Urinary tract infection
|
3.9%
4/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Investigations
Blood creatinine increased
|
8.7%
9/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.6%
14/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
3.1%
3/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.7%
10/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
5/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
6.1%
6/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Nervous system disorders
Dizziness
|
7.8%
8/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Nervous system disorders
Headache
|
24.3%
25/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
22.4%
22/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
11/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
15.3%
15/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.6%
13/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
11.2%
11/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
7/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
7.1%
7/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.8%
6/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
4.1%
4/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
9/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
6.1%
6/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
7/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
1.0%
1/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
3/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
5.1%
5/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
9/103
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
2.0%
2/98
202 participants were randomized (103 imatinib \& 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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