Trial Outcomes & Findings for A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene (NCT NCT00237185)
NCT ID: NCT00237185
Last Updated: 2014-08-19
Results Overview
Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.
COMPLETED
PHASE2
148 participants
Month 36
2014-08-19
Participant Flow
Participant milestones
| Measure |
Imatinib Mesylate 400 mg
imatinib mesylate 400 mg once daily
|
Imatinib Mesylate 600 mg
imatinib mesylate 600 mg once daily
|
|---|---|---|
|
Core
STARTED
|
74
|
74
|
|
Core
Treated Participants
|
73
|
74
|
|
Core
COMPLETED
|
30
|
37
|
|
Core
NOT COMPLETED
|
44
|
37
|
|
Extension
STARTED
|
24
|
32
|
|
Extension
COMPLETED
|
8
|
13
|
|
Extension
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate 400 mg
imatinib mesylate 400 mg once daily
|
Imatinib Mesylate 600 mg
imatinib mesylate 600 mg once daily
|
|---|---|---|
|
Core
Adverse Event
|
3
|
4
|
|
Core
Abnormal laboratory value
|
0
|
4
|
|
Core
Abnormal test procedure results
|
1
|
0
|
|
Core
Lack of Efficacy
|
30
|
23
|
|
Core
Protocol Violation
|
1
|
1
|
|
Core
Withdrawal by Subject
|
4
|
4
|
|
Core
Administrative problems
|
0
|
1
|
|
Core
Death
|
4
|
0
|
|
Core
Determined ineligible post randomization
|
1
|
0
|
|
Extension
Adverse Event
|
1
|
0
|
|
Extension
Abnormal laboratory value
|
0
|
1
|
|
Extension
Lack of Efficacy
|
9
|
14
|
|
Extension
Condition no longer required study drug
|
0
|
1
|
|
Extension
Withdrawal by Subject
|
3
|
2
|
|
Extension
Lost to Follow-up
|
1
|
0
|
|
Extension
Administrative problems
|
1
|
0
|
|
Extension
Death
|
1
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
52.2 Years
STANDARD_DEVIATION 11.12 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 36Population: Treatment population: The treatment population included all randomized participants who received at least one dose of study medication.
Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Best Tumor Response (Core)
Complete response
|
0 participants
|
1 participants
|
|
Best Tumor Response (Core)
Partial response
|
49 participants
|
49 participants
|
|
Best Tumor Response (Core)
Stable disease
|
10 participants
|
13 participants
|
|
Best Tumor Response (Core)
Progressive disease
|
12 participants
|
6 participants
|
|
Best Tumor Response (Core)
Not evaluable
|
2 participants
|
3 participants
|
|
Best Tumor Response (Core)
Unknown
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Month 156Population: Treatment population: the treatment population included all participants who had at least one dose of study medication.
Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Best Tumor Response (Core + Extension)
Complete response
|
1 participants
|
2 participants
|
|
Best Tumor Response (Core + Extension)
Partial response
|
49 participants
|
48 participants
|
|
Best Tumor Response (Core + Extension)
Stable disease
|
10 participants
|
13 participants
|
|
Best Tumor Response (Core + Extension)
Progressive disease
|
11 participants
|
6 participants
|
|
Best Tumor Response (Core + Extension)
Not evaluable
|
2 participants
|
3 participants
|
|
Best Tumor Response (Core + Extension)
Unknown
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to the date of death during the core period, up to 36 months.Population: Treatment population: the treatment population included all participants who had at least one dose of study medication.
Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Overall Survival (Core)
|
NA months
The median survival had not been reached.
|
NA months
The median survival has not been reached.
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months.Population: Treatment population: the treatment population included all participants who had at least one dose of study medication.
Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Overall Survival (Core + Extension)
|
55.9 months
Interval 34.6 to 85.9
|
57.1 months
Interval 43.8 to 99.7
|
SECONDARY outcome
Timeframe: Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months.Population: Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.
Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=49 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=50 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Duration of Response (Core)
|
113 weeks
Interval 83.0 to
There were not enough events (CRs and PRs) to calculate the upper limit.
|
123 weeks
Interval 79.0 to
There were not enough events (CRs and PRs) to calculate the upper limit.
|
SECONDARY outcome
Timeframe: Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 monthsPopulation: Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.
Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=49 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=50 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Duration of Response (Core + Extension)
|
27 months
Interval 22.0 to 46.0
|
30 months
Interval 18.0 to 56.0
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.Population: Treatment population: the treatment population included all participants who had at least one dose of study medication.
Progression free survival was analyzed as a time to event for each participant. If a participant had no event, then the PFS was censored at the last tumor assessment.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Progression Free Survival (PFS) (Core + Extension)
|
19.3 months
Interval 16.4 to 28.9
|
25.2 months
Interval 16.4 to 33.8
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months.Population: Treatment population: the treatment population included all participants who received at least one dose of study medication.
Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis ate the time of their last tumor assessment.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Time to Treatment Failure (Core)
|
84 weeks
Interval 71.0 to 107.0
|
84 weeks
Interval 71.0 to 144.0
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month.Population: Treatment population: the treatment population included all participants who received at least one dose of study medication.
Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Time to Treatment Failure (Core + Extension)
|
19 months
Interval 16.0 to 25.0
|
19 months
Interval 16.0 to 33.0
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months.Population: Treatment population: the treatment population included all participants who received at least one dose of study medication.
Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Time to Onset of Response (Core)
|
13 weeks
Interval 12.0 to 24.0
|
12 weeks
Interval 12.0 to 22.0
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months.Population: Treatment population: the treatment population included all participants who received at least one dose of study medication.
Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Time to Onset of Response (Core + Extension)
|
3 months
Interval 3.0 to 6.0
|
3 months
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.Population: Treatment population: the treatment population included all participants who received at least one dose of study medication.
Time to progression was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.
Outcome measures
| Measure |
Imatinib Mesylate 400 mg
n=73 Participants
400 mg
Imatinib mesylate
|
Imatinib Mesylate 600 mg
n=74 Participants
600 mg
Imatinib mesylate
|
|---|---|---|
|
Time to Progression (Core + Extension)
|
19.8 months
Interval 16.4 to 29.0
|
25.5 months
Interval 16.5 to 41.5
|
Adverse Events
Imatinib Mesylate 400 mg
Imatinib Mesylate 600 mg
Serious adverse events
| Measure |
Imatinib Mesylate 400 mg
n=73 participants at risk
400 mg
|
Imatinib Mesylate 600 mg
n=74 participants at risk
600 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
2.7%
2/73
|
5.4%
4/74
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/73
|
1.4%
1/74
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
2/73
|
0.00%
0/74
|
|
Cardiac disorders
Bradyarrhythmia
|
1.4%
1/73
|
0.00%
0/74
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/73
|
1.4%
1/74
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/73
|
1.4%
1/74
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/73
|
1.4%
1/74
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
6.8%
5/73
|
4.1%
3/74
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/73
|
1.4%
1/74
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/73
|
1.4%
1/74
|
|
Gastrointestinal disorders
Colovesical fistula
|
1.4%
1/73
|
0.00%
0/74
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/73
|
0.00%
0/74
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
0.00%
0/73
|
2.7%
2/74
|
|
Gastrointestinal disorders
Diverticular perforation NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/73
|
0.00%
0/74
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage NOS
|
4.1%
3/73
|
2.7%
2/74
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/73
|
0.00%
0/74
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/73
|
1.4%
1/74
|
|
Gastrointestinal disorders
Inflammatory bowel disease NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Gastrointestinal disorders
Intestinal obstruction NOS
|
2.7%
2/73
|
2.7%
2/74
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/73
|
1.4%
1/74
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/73
|
4.1%
3/74
|
|
Gastrointestinal disorders
Pancreatitis NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Gastrointestinal disorders
Small intestinal obstruction NOS
|
4.1%
3/73
|
2.7%
2/74
|
|
Gastrointestinal disorders
Vomiting NOS
|
1.4%
1/73
|
2.7%
2/74
|
|
General disorders
Anasarca
|
1.4%
1/73
|
0.00%
0/74
|
|
General disorders
Asthenia
|
0.00%
0/73
|
1.4%
1/74
|
|
General disorders
Chest pain
|
1.4%
1/73
|
1.4%
1/74
|
|
General disorders
Disease progression NOS
|
1.4%
1/73
|
1.4%
1/74
|
|
General disorders
Inflammation NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
General disorders
Oedema peripheral
|
1.4%
1/73
|
0.00%
0/74
|
|
General disorders
Pain NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
General disorders
Pain exacerbated
|
1.4%
1/73
|
0.00%
0/74
|
|
General disorders
Pyrexia
|
4.1%
3/73
|
2.7%
2/74
|
|
General disorders
Rigors
|
1.4%
1/73
|
0.00%
0/74
|
|
Hepatobiliary disorders
Cholangitis NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Hepatobiliary disorders
Cholecystitis NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/73
|
1.4%
1/74
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/73
|
1.4%
1/74
|
|
Infections and infestations
Abdominal abscess NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Abscess intestinal
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/73
|
1.4%
1/74
|
|
Infections and infestations
Bronchopneumonia NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/73
|
1.4%
1/74
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/73
|
1.4%
1/74
|
|
Infections and infestations
Klebsiella infection NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Lung infection NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Orchitis NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Pneumonia NOS
|
1.4%
1/73
|
1.4%
1/74
|
|
Infections and infestations
Pneumonia primary atypical
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Pseudomonas infection NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Infections and infestations
Sepsis NOS
|
2.7%
2/73
|
0.00%
0/74
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Tooth abscess
|
1.4%
1/73
|
0.00%
0/74
|
|
Infections and infestations
Urinary tract infection NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Infections and infestations
Urosepsis
|
0.00%
0/73
|
1.4%
1/74
|
|
Infections and infestations
Wound infection
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Intestinal anastomotic leak
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/73
|
1.4%
1/74
|
|
Injury, poisoning and procedural complications
Postoperative haematoma
|
0.00%
0/73
|
1.4%
1/74
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Wound NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.4%
1/73
|
0.00%
0/74
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.4%
1/73
|
0.00%
0/74
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/73
|
1.4%
1/74
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/73
|
1.4%
1/74
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/73
|
0.00%
0/74
|
|
Investigations
Blood creatine phosphokinase increased
|
1.4%
1/73
|
0.00%
0/74
|
|
Investigations
Blood creatinine increased
|
0.00%
0/73
|
1.4%
1/74
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/73
|
1.4%
1/74
|
|
Investigations
Liver function test abnormal
|
2.7%
2/73
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Dehydration
|
4.1%
3/73
|
1.4%
1/74
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/73
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/73
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/73
|
0.00%
0/74
|
|
Metabolism and nutrition disorders
Malnutrition NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73
|
0.00%
0/74
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/73
|
0.00%
0/74
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/73
|
1.4%
1/74
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/73
|
1.4%
1/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
4.1%
3/73
|
1.4%
1/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/73
|
1.4%
1/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.1%
3/73
|
1.4%
1/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.4%
1/73
|
0.00%
0/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.4%
1/73
|
2.7%
2/74
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
1.4%
1/73
|
0.00%
0/74
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/73
|
1.4%
1/74
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/73
|
0.00%
0/74
|
|
Nervous system disorders
Convulsions NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Nervous system disorders
Dizziness
|
0.00%
0/73
|
1.4%
1/74
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/73
|
0.00%
0/74
|
|
Nervous system disorders
Guillain Barre syndrome
|
1.4%
1/73
|
0.00%
0/74
|
|
Nervous system disorders
Headache
|
1.4%
1/73
|
0.00%
0/74
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/73
|
1.4%
1/74
|
|
Renal and urinary disorders
Renal colic
|
1.4%
1/73
|
0.00%
0/74
|
|
Renal and urinary disorders
Renal failure NOS
|
0.00%
0/73
|
2.7%
2/74
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
1.4%
1/73
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/73
|
2.7%
2/74
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/73
|
4.1%
3/74
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/73
|
1.4%
1/74
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73
|
1.4%
1/74
|
|
Skin and subcutaneous tissue disorders
Contusion
|
1.4%
1/73
|
0.00%
0/74
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/73
|
0.00%
0/74
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Surgical and medical procedures
Hysterectomy
|
1.4%
1/73
|
0.00%
0/74
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/73
|
1.4%
1/74
|
|
Surgical and medical procedures
Lung operation NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Surgical and medical procedures
Operation NOS
|
9.6%
7/73
|
8.1%
6/74
|
|
Surgical and medical procedures
Radiofrequency ablation
|
0.00%
0/73
|
1.4%
1/74
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/73
|
1.4%
1/74
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/73
|
1.4%
1/74
|
|
Vascular disorders
Deep vein thrombosis
|
2.7%
2/73
|
1.4%
1/74
|
|
Vascular disorders
Haemorrhage NOS
|
0.00%
0/73
|
1.4%
1/74
|
|
Vascular disorders
Peripheral vascular disorder NOS
|
1.4%
1/73
|
0.00%
0/74
|
|
Vascular disorders
Petechiae
|
1.4%
1/73
|
0.00%
0/74
|
Other adverse events
| Measure |
Imatinib Mesylate 400 mg
n=73 participants at risk
400 mg
|
Imatinib Mesylate 600 mg
n=74 participants at risk
600 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
16.4%
12/73
|
17.6%
13/74
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
5.5%
4/73
|
6.8%
5/74
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.2%
6/73
|
9.5%
7/74
|
|
Eye disorders
Conjunctival haemorrhage
|
4.1%
3/73
|
8.1%
6/74
|
|
Eye disorders
Conjunctival hyperaemia
|
2.7%
2/73
|
5.4%
4/74
|
|
Eye disorders
Eye irritation
|
5.5%
4/73
|
4.1%
3/74
|
|
Eye disorders
Eyelid oedema
|
6.8%
5/73
|
8.1%
6/74
|
|
Eye disorders
Lacrimation increased
|
16.4%
12/73
|
17.6%
13/74
|
|
Eye disorders
Vision blurred
|
8.2%
6/73
|
2.7%
2/74
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.2%
6/73
|
12.2%
9/74
|
|
Gastrointestinal disorders
Abdominal distension
|
9.6%
7/73
|
14.9%
11/74
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
35.6%
26/73
|
33.8%
25/74
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.5%
15/73
|
14.9%
11/74
|
|
Gastrointestinal disorders
Constipation
|
9.6%
7/73
|
9.5%
7/74
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
58.9%
43/73
|
68.9%
51/74
|
|
Gastrointestinal disorders
Dyspepsia
|
15.1%
11/73
|
14.9%
11/74
|
|
Gastrointestinal disorders
Flatulence
|
30.1%
22/73
|
33.8%
25/74
|
|
Gastrointestinal disorders
Frequent bowel movements
|
2.7%
2/73
|
5.4%
4/74
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.5%
4/73
|
10.8%
8/74
|
|
Gastrointestinal disorders
Loose stools
|
12.3%
9/73
|
9.5%
7/74
|
|
Gastrointestinal disorders
Nausea
|
61.6%
45/73
|
73.0%
54/74
|
|
Gastrointestinal disorders
Vomiting NOS
|
37.0%
27/73
|
33.8%
25/74
|
|
General disorders
Asthenia
|
5.5%
4/73
|
2.7%
2/74
|
|
General disorders
Chest pain
|
1.4%
1/73
|
5.4%
4/74
|
|
General disorders
Fatigue
|
47.9%
35/73
|
52.7%
39/74
|
|
General disorders
Influenza like illness
|
2.7%
2/73
|
5.4%
4/74
|
|
General disorders
Lethargy
|
5.5%
4/73
|
4.1%
3/74
|
|
General disorders
Oedema NOS
|
9.6%
7/73
|
17.6%
13/74
|
|
General disorders
Oedema peripheral
|
37.0%
27/73
|
32.4%
24/74
|
|
General disorders
Pain NOS
|
4.1%
3/73
|
9.5%
7/74
|
|
General disorders
Pyrexia
|
21.9%
16/73
|
14.9%
11/74
|
|
General disorders
Rigors
|
9.6%
7/73
|
6.8%
5/74
|
|
Infections and infestations
Gastroenteritis viral NOS
|
0.00%
0/73
|
5.4%
4/74
|
|
Infections and infestations
Influenza
|
5.5%
4/73
|
4.1%
3/74
|
|
Infections and infestations
Nasopharyngitis
|
20.5%
15/73
|
27.0%
20/74
|
|
Infections and infestations
Sinusitis NOS
|
5.5%
4/73
|
4.1%
3/74
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
13.7%
10/73
|
17.6%
13/74
|
|
Infections and infestations
Urinary tract infection NOS
|
2.7%
2/73
|
10.8%
8/74
|
|
Investigations
Liver function test abnormal
|
5.5%
4/73
|
6.8%
5/74
|
|
Investigations
Weight decreased
|
2.7%
2/73
|
5.4%
4/74
|
|
Metabolism and nutrition disorders
Anorexia
|
6.8%
5/73
|
2.7%
2/74
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/73
|
8.1%
6/74
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
7/73
|
14.9%
11/74
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.9%
16/73
|
25.7%
19/74
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.1%
3/73
|
6.8%
5/74
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
46.6%
34/73
|
58.1%
43/74
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
3/73
|
6.8%
5/74
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.0%
8/73
|
12.2%
9/74
|
|
Nervous system disorders
Dizziness
|
12.3%
9/73
|
9.5%
7/74
|
|
Nervous system disorders
Dysgeusia
|
2.7%
2/73
|
14.9%
11/74
|
|
Nervous system disorders
Headache
|
30.1%
22/73
|
39.2%
29/74
|
|
Nervous system disorders
Hypoaesthesia
|
2.7%
2/73
|
5.4%
4/74
|
|
Psychiatric disorders
Anxiety
|
11.0%
8/73
|
6.8%
5/74
|
|
Psychiatric disorders
Depression
|
5.5%
4/73
|
4.1%
3/74
|
|
Psychiatric disorders
Insomnia
|
19.2%
14/73
|
17.6%
13/74
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis NOS
|
5.5%
4/73
|
4.1%
3/74
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
6/73
|
9.5%
7/74
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
5/73
|
4.1%
3/74
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.3%
9/73
|
6.8%
5/74
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.2%
6/73
|
5.4%
4/74
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
4/73
|
6.8%
5/74
|
|
Skin and subcutaneous tissue disorders
Contusion
|
5.5%
4/73
|
2.7%
2/74
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
5/73
|
5.4%
4/74
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/73
|
5.4%
4/74
|
|
Skin and subcutaneous tissue disorders
Face oedema
|
6.8%
5/73
|
10.8%
8/74
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
53.4%
39/73
|
52.7%
39/74
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction NOS
|
0.00%
0/73
|
5.4%
4/74
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
2/73
|
8.1%
6/74
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
32.9%
24/73
|
44.6%
33/74
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
5.5%
4/73
|
2.7%
2/74
|
|
Vascular disorders
Flushing
|
8.2%
6/73
|
6.8%
5/74
|
Additional Information
Study Director
Novartis
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