Trial Outcomes & Findings for PXD101 in Treating Patients With Acute Myeloid Leukemia (NCT NCT00357032)
NCT ID: NCT00357032
Last Updated: 2018-04-17
Results Overview
Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles. Per International Working Group criteria: Complete Response (CR): Repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2018-04-17
Participant Flow
Participant milestones
| Measure |
Treatment (Belinostat)
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PXD101 in Treating Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Belinostat)
n=12 Participants
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearClinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles. Per International Working Group criteria: Complete Response (CR): Repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia
Outcome measures
| Measure |
Treatment (Belinostat)
n=12 Participants
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Complete Response Rate
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: Up to 1 yearSurvival endpoints will be summarized by the method of Kaplan-Meier
Outcome measures
| Measure |
Treatment (Belinostat)
n=12 Participants
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
9.1 Months
Interval 0.5 to 13.5
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: There were no formal CRs or PRs seen among the first cohort of 12 patients, resulting in the study's closure. As a result data were not collected.The study was completed as planned and stopped due to futility as written per protocol. It was not terminated prematurely as accrual proceeded per protocol.
From time of documented treatment response (CR or PR) until progression of death. Complete Response (CR): Repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia. Partial Resonse (PR): requires the same hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to a post-treatment value of 5% to 25% in the bone marrow aspirate. (If the pre-treatment blast percentage was 50-100%, this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49%, this must decrease by at least half to a value greater than 5%.) A value ≤ 5% is also considered a PR if Auer rods are present.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearAssessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 and above toxicities possibly, probably or definitely related to treatment.
Outcome measures
| Measure |
Treatment (Belinostat)
n=12 Participants
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Toxicity Summary
Grade 3 : Dehydration
|
1 participants
|
|
Toxicity Summary
Grade 3 : Febrile neutropenia
|
1 participants
|
|
Toxicity Summary
Grade 3 : Hematoma
|
0 participants
|
|
Toxicity Summary
Grade 3 : Mucositis/stomatitis
|
1 participants
|
|
Toxicity Summary
Grade 3 : Nausea
|
1 participants
|
|
Toxicity Summary
Grade 3 : Prolonged QTc interval
|
1 participants
|
|
Toxicity Summary
Grade 3 : Sodium, serum-low
|
1 participants
|
|
Toxicity Summary
Grade 4 : Dehydration
|
0 participants
|
|
Toxicity Summary
Grade 4 : Febrile neutropenia
|
0 participants
|
|
Toxicity Summary
Grade 4 : Hematoma
|
1 participants
|
|
Toxicity Summary
Grade 4 : Mucositis/stomatitis
|
0 participants
|
|
Toxicity Summary
Grade 4 : Nausea
|
0 participants
|
|
Toxicity Summary
Grade 4 : Prolonged QTc interval
|
0 participants
|
|
Toxicity Summary
Grade 4 : Sodium, serum-low
|
0 participants
|
Adverse Events
Treatment (Belinostat)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Belinostat)
n=12 participants at risk
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
2/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Bladder infection
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Intracranial hemorrhage
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Treatment (Belinostat)
n=12 participants at risk
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
belinostat: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
58.3%
7/12 • Number of events 27 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
1/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing loss
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Photophobia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
3/12 • Number of events 4 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
8/12 • Number of events 15 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
25.0%
3/12 • Number of events 9 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Facial pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
50.0%
6/12 • Number of events 15 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
25.0%
3/12 • Number of events 6 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu-like symptoms
|
16.7%
2/12 • Number of events 4 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
1/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
41.7%
5/12 • Number of events 13 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
3/12 • Number of events 14 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
4/12 • Number of events 14 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
33.3%
4/12 • Number of events 9 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperbilirubinemia
|
16.7%
2/12 • Number of events 9 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
16.7%
2/12 • Number of events 6 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
33.3%
4/12 • Number of events 9 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
50.0%
6/12 • Number of events 22 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
58.3%
7/12 • Number of events 23 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • Number of events 6 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
8/12 • Number of events 19 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
25.0%
3/12 • Number of events 5 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
1/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
6/12 • Number of events 21 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
6/12 • Number of events 14 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
3/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.7%
5/12 • Number of events 7 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
41.7%
5/12 • Number of events 14 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
2/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 4 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
2/12 • Number of events 4 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 5 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Mental status changes
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Taste alteration
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
3/12 • Number of events 3 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
16.7%
2/12 • Number of events 2 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.3%
1/12 • Number of events 4 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
8.3%
1/12 • Number of events 1 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
33.3%
4/12 • Number of events 7 • Adverse events were collected over a period of 12 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60