Trial Outcomes & Findings for Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia (NCT NCT00254423)
NCT ID: NCT00254423
Last Updated: 2026-01-15
Results Overview
Major Molecular Response (MMR) is BCR-ABL/ABL ratio \</= 0.05
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
12 months
Results posted on
2026-01-15
Participant Flow
Participant milestones
| Measure |
Dasatinib
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Dasatinib
n=150 Participants
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
135 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=14 Participants
|
|
Age, Continuous
|
48 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
139 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMajor Molecular Response (MMR) is BCR-ABL/ABL ratio \</= 0.05
Outcome measures
| Measure |
Dasatinib
n=137 Participants
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Number of Participants With a Major Molecular Response at 12 Months
|
103 Participants
|
SECONDARY outcome
Timeframe: Up to 19 years, 4 months and 6 daysTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Dasatinib
n=150 Participants
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Overall Survival
|
NA Months
Interval 0.3 to 232.0
OS median not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 19 years, 4 months and 6 daysComplete Cytogenic Response (CCR) is Ph positive 0%
Outcome measures
| Measure |
Dasatinib
n=150 Participants
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Participants With Complete Cytogenic Response (CCR)
|
140 Participants
|
SECONDARY outcome
Timeframe: Up to 19 years, 4 months and 6 daysABL mutations will be assesses during treatment through Quanitiative PCR (qPCR) (RT-qPCR) or ABM mutational analysis using Sanger Sequencing or next-Generation Sequencing (NGS).
Outcome measures
| Measure |
Dasatinib
n=150 Participants
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Participants Who Developed the ABL Mutations
|
7 Participants
|
Adverse Events
Dasatinib
Serious events: 34 serious events
Other events: 144 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dasatinib
n=150 participants at risk
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
General disorders
Abdominal Pain
|
2.0%
3/150 • Number of events 3 • Up to 19 years, 4 months and 6 days
|
|
Immune system disorders
Allergic reaction
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Immune system disorders
Allergy-Other : Angioedema/allergic reaction to Enalapril
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Immune system disorders
Allergy-Other : Study drug (Dasatinib) overdose
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Atrial Flutter
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Biventricular Heart Failure
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.3%
2/150 • Number of events 2 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Cardiac Pain
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
Cellulitis
|
2.0%
3/150 • Number of events 5 • Up to 19 years, 4 months and 6 days
|
|
General disorders
Chest Pain
|
2.0%
3/150 • Number of events 3 • Up to 19 years, 4 months and 6 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Congestive Heart Failure
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
Encephalopathy
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
General disorders
Fever
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
Gastritis
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
1.3%
2/150 • Number of events 3 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
headache
|
1.3%
2/150 • Number of events 2 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
Infection
|
2.0%
3/150 • Number of events 3 • Up to 19 years, 4 months and 6 days
|
|
Surgical and medical procedures
Left distal biceps tendon repair
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
General disorders
monoclonal gammopathy of undetermined significance
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Myocardial Infarction
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
Nausea
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
Neurology/Potential Drug Dependency
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
General disorders
Pain
|
1.3%
2/150 • Number of events 3 • Up to 19 years, 4 months and 6 days
|
|
General disorders
Back Pain
|
0.67%
1/150 • Number of events 2 • Up to 19 years, 4 months and 6 days
|
|
General disorders
Bone Pain
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
3/150 • Number of events 4 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
Pneumonia
|
2.0%
3/150 • Number of events 3 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
Prolonged QTc
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
Syncope
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the skin -back of left ear
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the Right Ear
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
|
Pregnancy, puerperium and perinatal conditions
unexpected pregnancy
|
0.67%
1/150 • Number of events 1 • Up to 19 years, 4 months and 6 days
|
Other adverse events
| Measure |
Dasatinib
n=150 participants at risk
Patients receive dasatinib PO QD for up to 15-18 years.
Dasatinib: Given PO
|
|---|---|
|
Skin and subcutaneous tissue disorders
ACNE
|
10.7%
16/150 • Number of events 20 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
ALKALINE PHOSPHATASE
|
5.3%
8/150 • Number of events 9 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
5.3%
8/150 • Number of events 12 • Up to 19 years, 4 months and 6 days
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY (OTHER)
|
5.3%
8/150 • Number of events 10 • Up to 19 years, 4 months and 6 days
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
10.0%
15/150 • Number of events 16 • Up to 19 years, 4 months and 6 days
|
|
Investigations
ALT SGPT
|
10.0%
15/150 • Number of events 30 • Up to 19 years, 4 months and 6 days
|
|
Blood and lymphatic system disorders
ANEMIA
|
18.0%
27/150 • Number of events 33 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
ANOREXIA
|
4.7%
7/150 • Number of events 7 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
5.3%
8/150 • Number of events 13 • Up to 19 years, 4 months and 6 days
|
|
Investigations
AST SGOT
|
16.7%
25/150 • Number of events 32 • Up to 19 years, 4 months and 6 days
|
|
Ear and labyrinth disorders
AUDITORY/EAR (OTHER)
|
5.3%
8/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Investigations
BILIRUBIN
|
5.3%
8/150 • Number of events 14 • Up to 19 years, 4 months and 6 days
|
|
Eye disorders
BLURRED VISION
|
22.0%
33/150 • Number of events 53 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA (OTHER)
|
4.7%
7/150 • Number of events 7 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
CARDIAC GENERAL (OTHER)
|
9.3%
14/150 • Number of events 18 • Up to 19 years, 4 months and 6 days
|
|
Investigations
CHOLESTEROL
|
4.7%
7/150 • Number of events 9 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
CONSTIPATION
|
34.0%
51/150 • Number of events 92 • Up to 19 years, 4 months and 6 days
|
|
General disorders
CONSTITUTIONAL SYMPTOMS (OTHER)
|
20.7%
31/150 • Number of events 48 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
26.0%
39/150 • Number of events 52 • Up to 19 years, 4 months and 6 days
|
|
Investigations
CREATININE
|
6.0%
9/150 • Number of events 9 • Up to 19 years, 4 months and 6 days
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN (OTHER)
|
22.7%
34/150 • Number of events 60 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
DIARRHEA
|
58.7%
88/150 • Number of events 219 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
DIZZINESS
|
45.3%
68/150 • Number of events 138 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
55.3%
83/150 • Number of events 188 • Up to 19 years, 4 months and 6 days
|
|
General disorders
EDEMA
|
8.0%
12/150 • Number of events 17 • Up to 19 years, 4 months and 6 days
|
|
General disorders
EDEMA: HEAD AND NECK
|
12.7%
19/150 • Number of events 30 • Up to 19 years, 4 months and 6 days
|
|
General disorders
EDEMA: LIMB
|
29.3%
44/150 • Number of events 68 • Up to 19 years, 4 months and 6 days
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
5.3%
8/150 • Number of events 11 • Up to 19 years, 4 months and 6 days
|
|
General disorders
FATIGUE
|
76.7%
115/150 • Number of events 269 • Up to 19 years, 4 months and 6 days
|
|
General disorders
FEVER WITHOUT NEUTROPENIA
|
31.3%
47/150 • Number of events 92 • Up to 19 years, 4 months and 6 days
|
|
Vascular disorders
FLUSHING
|
4.7%
7/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
GASTROINTESTINAL (OTHER)
|
26.0%
39/150 • Number of events 61 • Up to 19 years, 4 months and 6 days
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
22.7%
34/150 • Number of events 56 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
4.7%
7/150 • Number of events 7 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
12.7%
19/150 • Number of events 28 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
5.3%
8/150 • Number of events 9 • Up to 19 years, 4 months and 6 days
|
|
Vascular disorders
HYPERTENSION
|
15.3%
23/150 • Number of events 25 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
6.0%
9/150 • Number of events 11 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
4.7%
7/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
8.7%
13/150 • Number of events 15 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
4.7%
7/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION
|
4.7%
7/150 • Number of events 7 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION (OTHER)
|
14.7%
22/150 • Number of events 38 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION UNKNOWN ANC (SINUS)
|
5.3%
8/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION W NORMAL ANC (LUNG - PNEUMONIA)
|
5.3%
8/150 • Number of events 10 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION W NORMAL ANC (SINUS)
|
5.3%
8/150 • Number of events 12 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION W NORMAL ANC (URINARY TRACT NOS)
|
5.3%
8/150 • Number of events 9 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
INFECTION WITHOUT NEUTROPENIA
|
6.7%
10/150 • Number of events 12 • Up to 19 years, 4 months and 6 days
|
|
Psychiatric disorders
INSOMNIA
|
16.0%
24/150 • Number of events 27 • Up to 19 years, 4 months and 6 days
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
5.3%
8/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
28.7%
43/150 • Number of events 65 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
MENTAL STATUS
|
4.7%
7/150 • Number of events 7 • Up to 19 years, 4 months and 6 days
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY (OTHER)
|
8.7%
13/150 • Number of events 15 • Up to 19 years, 4 months and 6 days
|
|
Psychiatric disorders
MOOD ALTERATION (ANXIETY)
|
16.0%
24/150 • Number of events 25 • Up to 19 years, 4 months and 6 days
|
|
Psychiatric disorders
MOOD ALTERATION (DEPRESSION)
|
14.0%
21/150 • Number of events 28 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
4.7%
7/150 • Number of events 7 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL (OTHER)
|
29.3%
44/150 • Number of events 63 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.3%
11/150 • Number of events 18 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
NAUSEA
|
52.7%
79/150 • Number of events 163 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
NEUROLOGY (OTHER)
|
26.0%
39/150 • Number of events 69 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
4.7%
7/150 • Number of events 11 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
22.7%
34/150 • Number of events 71 • Up to 19 years, 4 months and 6 days
|
|
Investigations
NEUTROPHILS (ANC/AGC)
|
7.3%
11/150 • Number of events 17 • Up to 19 years, 4 months and 6 days
|
|
Eye disorders
OCULAR VISUAL (OTHER)
|
40.0%
60/150 • Number of events 130 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
PAIN (ABDOMEN NOS)
|
14.7%
22/150 • Number of events 30 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
PAIN (BACK)
|
15.3%
23/150 • Number of events 31 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
PAIN (BONE)
|
16.0%
24/150 • Number of events 35 • Up to 19 years, 4 months and 6 days
|
|
General disorders
PAIN (CHEST/THORAX)
|
10.7%
16/150 • Number of events 17 • Up to 19 years, 4 months and 6 days
|
|
General disorders
PAIN (EXTREMITY-LIMB)
|
12.7%
19/150 • Number of events 24 • Up to 19 years, 4 months and 6 days
|
|
Nervous system disorders
PAIN (HEAD/HEADACHE)
|
48.0%
72/150 • Number of events 132 • Up to 19 years, 4 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
PAIN (JOINT)
|
9.3%
14/150 • Number of events 16 • Up to 19 years, 4 months and 6 days
|
|
General disorders
PAIN (MUSCLE)
|
36.7%
55/150 • Number of events 101 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
PAIN (ORAL CAVITY)
|
13.3%
20/150 • Number of events 37 • Up to 19 years, 4 months and 6 days
|
|
General disorders
PAIN (OTHER)
|
20.0%
30/150 • Number of events 51 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
PAIN (THROAT/PHARYNX/LARYNX)
|
6.7%
10/150 • Number of events 10 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
PALPITATIONS
|
12.0%
18/150 • Number of events 26 • Up to 19 years, 4 months and 6 days
|
|
Eye disorders
PERIORBITAL EDEMA
|
13.3%
20/150 • Number of events 27 • Up to 19 years, 4 months and 6 days
|
|
Investigations
PLATELETS
|
22.0%
33/150 • Number of events 61 • Up to 19 years, 4 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
26.0%
39/150 • Number of events 72 • Up to 19 years, 4 months and 6 days
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.0%
12/150 • Number of events 18 • Up to 19 years, 4 months and 6 days
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
5.3%
8/150 • Number of events 12 • Up to 19 years, 4 months and 6 days
|
|
General disorders
PULMONARY (OTHER)
|
12.7%
19/150 • Number of events 20 • Up to 19 years, 4 months and 6 days
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
30.0%
45/150 • Number of events 86 • Up to 19 years, 4 months and 6 days
|
|
Renal and urinary disorders
RENAL/GENITOURINARY (OTHER)
|
10.0%
15/150 • Number of events 17 • Up to 19 years, 4 months and 6 days
|
|
General disorders
RIGORS/CHILLS
|
8.0%
12/150 • Number of events 13 • Up to 19 years, 4 months and 6 days
|
|
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE (OTHER)
|
8.7%
13/150 • Number of events 14 • Up to 19 years, 4 months and 6 days
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
7.3%
11/150 • Number of events 12 • Up to 19 years, 4 months and 6 days
|
|
General disorders
SWEATING
|
9.3%
14/150 • Number of events 14 • Up to 19 years, 4 months and 6 days
|
|
General disorders
ULCERATION
|
11.3%
17/150 • Number of events 21 • Up to 19 years, 4 months and 6 days
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
6.7%
10/150 • Number of events 14 • Up to 19 years, 4 months and 6 days
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
4.7%
7/150 • Number of events 8 • Up to 19 years, 4 months and 6 days
|
|
Gastrointestinal disorders
VOMITING
|
30.7%
46/150 • Number of events 94 • Up to 19 years, 4 months and 6 days
|
|
Eye disorders
WATERY EYE
|
19.3%
29/150 • Number of events 33 • Up to 19 years, 4 months and 6 days
|
|
Eye disorders
WATERY EYES
|
19.3%
29/150 • Number of events 40 • Up to 19 years, 4 months and 6 days
|
|
Investigations
WEIGHT GAIN
|
8.0%
12/150 • Number of events 13 • Up to 19 years, 4 months and 6 days
|
|
Investigations
WEIGHT LOSS
|
8.0%
12/150 • Number of events 14 • Up to 19 years, 4 months and 6 days
|
Additional Information
Lucia Masarova MD/Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 832-750-4211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place