Trial Outcomes & Findings for Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST) (NCT NCT00867113)
NCT ID: NCT00867113
Last Updated: 2018-03-14
Results Overview
Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Baseline up to 60 months
Results posted on
2018-03-14
Participant Flow
Total of 113 subjects were screened and 91 were enrolled..
Participant milestones
| Measure |
Imatinib
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Treatment Period
STARTED
|
91
|
|
Treatment Period
Safety Set
|
91
|
|
Treatment Period
Full Analysis Set (FAS)
|
91
|
|
Treatment Period
COMPLETED
|
46
|
|
Treatment Period
NOT COMPLETED
|
45
|
|
Post Treatment After Survival Follow-up
STARTED
|
68
|
|
Post Treatment After Survival Follow-up
COMPLETED
|
57
|
|
Post Treatment After Survival Follow-up
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Imatinib
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Treatment Period
Adverse Event
|
15
|
|
Treatment Period
Death
|
2
|
|
Treatment Period
Withdrawal by Subject
|
19
|
|
Treatment Period
Lost to Follow-up
|
3
|
|
Treatment Period
Administrative problems
|
1
|
|
Treatment Period
Disease progression/relapse
|
1
|
|
Treatment Period
Protocol Violation
|
4
|
|
Post Treatment After Survival Follow-up
Death
|
1
|
|
Post Treatment After Survival Follow-up
Withdrawal by Subject
|
1
|
|
Post Treatment After Survival Follow-up
Lost to Follow-up
|
5
|
|
Post Treatment After Survival Follow-up
Administrative problems
|
4
|
Baseline Characteristics
Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
Baseline characteristics by cohort
| Measure |
Imatinib
n=91 Participants
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 12.64 • n=99 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
|
ECOG Status
ECOG = 0
|
59 Participants
n=99 Participants
|
|
ECOG Status
ECOG = 1
|
32 Participants
n=99 Participants
|
|
Primary lesion location
Gastric
|
50 participant
n=99 Participants
|
|
Primary lesion location
Duodenum
|
4 participant
n=99 Participants
|
|
Primary lesion location
Jejunum ileum
|
21 participant
n=99 Participants
|
|
Primary lesion location
Rectum
|
1 participant
n=99 Participants
|
|
Primary lesion location
Other
|
15 participant
n=99 Participants
|
|
Primary lesion location
Abdomen
|
1 participant
n=99 Participants
|
|
Primary lesion location
Abdominal; Proximal Jejunal
|
1 participant
n=99 Participants
|
|
Primary lesion location
Exact Location In Small Bowel Not Identified
|
1 participant
n=99 Participants
|
|
Primary lesion location
Gastric Serosa-Min Invasion Outer Musc Prop
|
1 participant
n=99 Participants
|
|
Primary lesion location
Ileum And Cecum
|
1 participant
n=99 Participants
|
|
Primary lesion location
Pelvis - Organ Of Origin Unknown
|
1 participant
n=99 Participants
|
|
Primary lesion location
Recto Vaginal
|
1 participant
n=99 Participants
|
|
Primary lesion location
Retroperitoneal Mass
|
1 participant
n=99 Participants
|
|
Primary lesion location
Sigmoid Colon
|
1 participant
n=99 Participants
|
|
Primary lesion location
Small Bowel
|
6 participant
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 60 monthsRecurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).
Outcome measures
| Measure |
Imatinib
n=91 Participants
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Recurrence-free Survival up to 60 Months
Subject with an event
|
9 participants with an event
|
|
Recurrence-free Survival up to 60 Months
Event = disease recurrence
|
7 participants with an event
|
|
Recurrence-free Survival up to 60 Months
Event=death
|
2 participants with an event
|
|
Recurrence-free Survival up to 60 Months
Subjects censored
|
82 participants with an event
|
PRIMARY outcome
Timeframe: Baseline up to 60 monthsRecurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated
Outcome measures
| Measure |
Imatinib
n=91 Participants
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
12 months
|
97.7 percentage of patients
Interval 91.1 to 99.4
|
|
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
18 months
|
97.7 percentage of patients
Interval 91.1 to 99.4
|
|
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
24 months
|
96.5 percentage of patients
Interval 89.6 to 98.9
|
|
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
36 months
|
95.1 percentage of patients
Interval 87.5 to 98.2
|
|
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
48 months
|
95.1 percentage of patients
Interval 87.5 to 98.2
|
|
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
60 months
|
90.1 percentage of patients
Interval 80.0 to 95.2
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 monthsOverall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
Outcome measures
| Measure |
Imatinib
n=91 Participants
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Overall Survival (OS) at 60 Months
subjects who died
|
3 participants
|
|
Overall Survival (OS) at 60 Months
subjects censored
|
88 participants
|
SECONDARY outcome
Timeframe: Baseline up to appoximately 60 monthsOverall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
Outcome measures
| Measure |
Imatinib
n=91 Participants
All subjects received in tablet form imatinib (STI571) 400 mg once daily.
|
|---|---|
|
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
24 months
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
36 months
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
48 months
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
12 months
|
100.00 percentage of participants
Interval 100.0 to 100.0
|
|
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
18 months
|
100.00 percentage of participants
Interval 100.0 to 100.0
|
|
Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
60 months
|
93.8 percentage of participants
Interval 82.0 to 98.0
|
Adverse Events
Imatinib
Serious events: 28 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib
n=91 participants at risk
Imatinib
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.4%
4/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
COLITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
NAUSEA
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
RETCHING
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
3.3%
3/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
VOMITING
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
CHEST PAIN
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
MALAISE
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
PAIN
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Immune system disorders
HYPERSENSITIVITY
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
ABDOMINAL INFECTION
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
APPENDICITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
CELLULITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
GASTROENTERITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
PERITONITIS
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
PNEUMONIA
|
4.4%
4/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
SIALOADENITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Injury, poisoning and procedural complications
FALL
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
HEPATIC ENZYME INCREASED
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
LIPASE INCREASED
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
WEIGHT DECREASED
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DESMOID TUMOUR
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAIR FOLLICLE TUMOUR BENIGN
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
3.3%
3/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
RADICULOPATHY
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Psychiatric disorders
DELIRIUM
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Psychiatric disorders
DEPRESSION
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Renal and urinary disorders
RENAL MASS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
ALVEOLITIS
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.1%
1/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Vascular disorders
HYPERTENSION
|
2.2%
2/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
Other adverse events
| Measure |
Imatinib
n=91 participants at risk
Imatinib
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.5%
15/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Ear and labyrinth disorders
VERTIGO
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Eye disorders
LACRIMATION INCREASED
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Eye disorders
PERIORBITAL OEDEMA
|
34.1%
31/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
24.2%
22/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
62.6%
57/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
15.4%
14/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
FLATULENCE
|
13.2%
12/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
NAUSEA
|
71.4%
65/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Gastrointestinal disorders
VOMITING
|
37.4%
34/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
CHILLS
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
FATIGUE
|
49.5%
45/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
OEDEMA
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
OEDEMA PERIPHERAL
|
19.8%
18/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
PAIN
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
PYREXIA
|
9.9%
9/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
General disorders
TEMPERATURE INTOLERANCE
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
SINUSITIS
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.0%
10/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
11.0%
10/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
WEIGHT INCREASED
|
9.9%
9/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
13.2%
12/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.0%
10/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
15.4%
14/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
17.6%
16/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.1%
11/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
40.7%
37/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
12.1%
11/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
14.3%
13/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
DIZZINESS
|
18.7%
17/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
DYSGEUSIA
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
HEADACHE
|
22.0%
20/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
PARAESTHESIA
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Nervous system disorders
SCIATICA
|
5.5%
5/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Psychiatric disorders
DEPRESSION
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Psychiatric disorders
INSOMNIA
|
8.8%
8/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.1%
11/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.1%
11/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
9.9%
9/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.6%
6/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
7.7%
7/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
26.4%
24/91 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER