Trial Outcomes & Findings for Ponatinib - Frontline for Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP) (NCT NCT01570868)
NCT ID: NCT01570868
Last Updated: 2025-12-08
Results Overview
Proportion of participants with previously-untreated accelerated phase CML attaining complete cytogenetic response (CCyR) at 6 months of treatment with Ponatinib classified according to suppression of the Philadelphia chromosome (Ph) by cytogenetics (FISH if cytogenetic analysis not informative, e.g., insufficient metaphases). CCyR defined as Ph positive 0%.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
6 months
Results posted on
2025-12-08
Participant Flow
Recruitment period: April 27, 2012 to May 12, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
Study terminated early.
Participant milestones
| Measure |
Ponatinib 45 mg
Ponatinib 45 mg orally, once daily.
|
Ponatinib 30 mg
Ponatinib 30 mg orally, once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
8
|
Reasons for withdrawal
| Measure |
Ponatinib 45 mg
Ponatinib 45 mg orally, once daily.
|
Ponatinib 30 mg
Ponatinib 30 mg orally, once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
1
|
|
Overall Study
FDA Recommendation
|
23
|
3
|
|
Overall Study
Physician Decision
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Ponatinib - Frontline for Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP)
Baseline characteristics by cohort
| Measure |
Ponatinib 45 mg
n=43 Participants
Ponatinib 45 mg orally, once daily.
|
Ponatinib 30 mg
n=8 Participants
Ponatinib 30 mg orally, once daily.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=37 Participants
|
42 years
n=37 Participants
|
43 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
24 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
27 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
51 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProportion of participants with previously-untreated accelerated phase CML attaining complete cytogenetic response (CCyR) at 6 months of treatment with Ponatinib classified according to suppression of the Philadelphia chromosome (Ph) by cytogenetics (FISH if cytogenetic analysis not informative, e.g., insufficient metaphases). CCyR defined as Ph positive 0%.
Outcome measures
| Measure |
Ponatinib 45 mg
n=42 Participants
Ponatinib 45 mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
|
Ponatinib 30 mg
n=8 Participants
Ponatinib 30mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
|
|---|---|---|
|
Number of Participants With Complete Cytogenetic Response (CCyR)
|
40 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsProportion of participants with previously-untreated accelerated phase CML receiving treatment of Ponatinib achieving a Complete cytogenetic response (CCyR). Classified according to suppression of the Philadelphia chromosome (Ph) by cytogenetics (FISH if cytogenetic analysis not informative, e.g., insufficient metaphases. CCyR is defined as Ph positive 0%.
Outcome measures
| Measure |
Ponatinib 45 mg
n=42 Participants
Ponatinib 45 mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
|
Ponatinib 30 mg
n=8 Participants
Ponatinib 30mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
|
|---|---|---|
|
Number of Participants With Complete Cytogenetic Response (CCyR)
|
42 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: One participant was not included in analysis.
Time to toxicity monitoring defined as any grade 3 or 4 drug-related non-hematologic adverse event that has not resolved to grade 2 or less after 6 weeks of optimal therapeutic management, or drug-related toxicity of any grade that in the opinion of the investigator prevents further therapy with ponatinib. Time to toxicity monitored using the Bayesian method of Thall, et al.
Outcome measures
| Measure |
Ponatinib 45 mg
n=43 Participants
Ponatinib 45 mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
|
Ponatinib 30 mg
n=8 Participants
Ponatinib 30mg orally, once daily. Dose escalation to 30 mg possible for participants with adverse events.
|
|---|---|---|
|
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant
Elevated Amylase
|
2 Participants
|
0 Participants
|
|
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant
Lipase Elevation
|
15 Participants
|
1 Participants
|
|
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant
Pancreatitis
|
7 Participants
|
2 Participants
|
|
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant
Abdominal Pain
|
1 Participants
|
0 Participants
|
|
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant
Hypertension
|
3 Participants
|
0 Participants
|
|
Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant
Elevated alanine aminotransferase (ALT)
|
2 Participants
|
0 Participants
|
Adverse Events
Ponatinib 45 mg
Serious events: 17 serious events
Other events: 35 other events
Deaths: 0 deaths
Ponatinib 30 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ponatinib 45 mg
n=43 participants at risk
Ponatinib 45 mg orally, once daily.
|
Ponatinib 30 mg
n=8 participants at risk
Ponatinib 30 mg orally, once daily.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/43 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Cardiac disorders
Chest Pain
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/43 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
General disorders
Fever
|
2.3%
1/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Vascular disorders
Hypertension
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Infections and infestations-Other
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Lung Infection
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Cardiac disorders
Myocardial infarction
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
General disorders
Non-Cardiac chest pain
|
2.3%
1/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
16.3%
7/43 • Number of events 10 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
25.0%
2/8 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Pelvic infection
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Seizure
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Stroke
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Surgical and medical procedures - Other, Hysterectomy
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Transient ischemic attacks
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Vascular disorders
Vaso-Occulusive diasease
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Vascular disorders
Bialteral superfical femoral artery occulsion
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Vascular disorders
Peripheral vascular disease
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
Other adverse events
| Measure |
Ponatinib 45 mg
n=43 participants at risk
Ponatinib 45 mg orally, once daily.
|
Ponatinib 30 mg
n=8 participants at risk
Ponatinib 30 mg orally, once daily.
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorders other
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/43 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Cardiac disorders
Chest Pain
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Cognitive disturbance
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Psychiatric disorders
Decreased libido
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Musculoskeletal and connective tissue disorders
decreased range of motion, joint
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Psychiatric disorders
Depression
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Eye disorders
Dry eye
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/43 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Endocrine disorders
Endocrine disorders
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/43 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
General disorders
Fever
|
4.7%
2/43 • Number of events 3 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Vascular disorders
Hypertension
|
7.0%
3/43 • Number of events 3 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Endocrine disorders
Hypothyroidism
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Investigations
Increased Alanine aminotransferase
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Investigations
Increased amylase
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Investigations
Increased Aspartate aminotransferase
|
2.3%
1/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Investigations
Increased GGT
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Investigations
Increased Lipase
|
23.3%
10/43 • Number of events 15 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Infection other
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Memory impairment
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Cardiac disorders
Myocardial Infarction
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Nervous system disorders
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
2.3%
1/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
General disorders
Pain
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
16.3%
7/43 • Number of events 7 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
25.0%
2/8 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Gastrointestinal disorders
Pelvic infection
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Stroke
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
11.6%
5/43 • Number of events 5 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/43 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Nervous system disorders
Transient ischemic attacks
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • Number of events 2 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Vascular disorders
Vascular disorders
|
7.0%
3/43 • Number of events 3 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Investigations
Weight gain
|
7.0%
3/43 • Number of events 3 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
12.5%
1/8 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
2.3%
1/43 • Number of events 1 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
0.00%
0/8 • Adverse event collection minimally every 4 weeks for total duration of therapy up to one year, study collection period to be 3 to 5 years.
|
Additional Information
Jorge Cortes, MD/Professor, Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place