Trial Outcomes & Findings for Bortezomib and Doxil for the Treatment of Patients With Acute Myelogenous Leukemia (NCT NCT01736943)
NCT ID: NCT01736943
Last Updated: 2021-02-24
Results Overview
The time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2021-02-24
Participant Flow
Participant milestones
| Measure |
Bortezomib + Doxil
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib and Doxil for the Treatment of Patients With Acute Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Bortezomib + Doxil
n=25 Participants
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Outcome measures
| Measure |
Bortezomib + Doxil
n=10 Participants
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Progression Free Survival
|
21 days
Interval 17.0 to
Upper value of the confidence interval was not reached.
|
SECONDARY outcome
Timeframe: Up to two yearsOverall survival wil be measured as the time from start of treatment to the Date of death or the last date the patient was known to be alive
Outcome measures
| Measure |
Bortezomib + Doxil
n=10 Participants
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Overall Survival
|
50 Days
Interval 41.0 to
Upper value of the confidence interval was not reached.
|
SECONDARY outcome
Timeframe: Up to two yearsToxicity will be evaluated based on the standard NCI Common Toxicity Criteria for Adverse Effects CTCAE) V.4.0 grading criteria.
Outcome measures
| Measure |
Bortezomib + Doxil
n=25 Participants
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Abdominal pain
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Alanine aminotransferase increased
|
3 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Anemia
|
17 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Constipation
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Hypokalemia
|
3 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Hyponatremia
|
7 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Hypotension
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Infections and infestations - Other, bacteremia
|
3 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Insomnia
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Lymphocyte count decreased
|
12 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Malaise
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Mucositis oral
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Nausea
|
15 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Neutrophil count decreased
|
10 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Peripheral sensory neuropathy
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Platelet count decreased
|
18 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Respiratory, thoracic and mediastinal disorders - Other, tachypnea
|
3 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Skin and subcutaneous tissue disorders - Other, Ecchymoses
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Vomiting
|
8 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
White blood cell decreased
|
14 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Anorexia
|
7 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Aspartate aminotransferase increased
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Chills
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Cough
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Diarrhea
|
9 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Dizziness
|
8 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Dyspnea
|
10 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Edema limbs
|
3 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Epitaxis
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Fatigue
|
15 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Febrile neutopenia
|
12 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Gastrointestinal disorders - Other, gum tenderness
|
3 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Generalized muscle weakness
|
4 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Headache
|
5 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Hypoalbuminemia
|
6 participants
|
|
Toxicity Information Recorded Will Include the Type, Severity, Time of Onset, Time of Resolution, and the Probable Association With the Study Regimen.
Hypocalcemia
|
4 participants
|
Adverse Events
Bortezomib + Doxil
Serious events: 10 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bortezomib + Doxil
n=25 participants at risk
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Infections and infestations
Bronchial infection
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
bronchopulmonary hemorrhage
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Infections and infestations
Catheter related infection
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Cardiac disorders
Heart failure
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasms benign, malignant and unspecified (incl cysts and polyps) - other, specify
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Nervous system disorders
Vasovagal reaction
|
4.0%
1/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
Other adverse events
| Measure |
Bortezomib + Doxil
n=25 participants at risk
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib: Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Doxil: Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
3/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
68.0%
17/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.0%
7/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Bloating
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Blood bilirubin increased
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Infections and infestations
Catheter related infection
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
General disorders
Chills
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Colitis
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Creatinine increased
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
36.0%
9/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Nervous system disorders
Dizziness
|
32.0%
8/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
10/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
General disorders
Edema limbs
|
12.0%
3/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
General disorders
Fatigue
|
60.0%
15/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
48.0%
12/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
General disorders
Fever
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Gum tenderness
|
12.0%
3/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Cardiac disorders
Heart failure
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Vascular disorders
Hematoma
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
24.0%
6/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
hypokalemia
|
12.0%
3/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.0%
7/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Psychiatric disorders
Insomnia
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Nervous system disorders
Lethargy
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Lymphocyte count decreased
|
48.0%
12/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
General disorders
Malaise
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other: body/pain sore
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
15/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
neutrophil count decreased
|
40.0%
10/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
General disorders
Pain
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain extremity
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Platelet count decreased
|
72.0%
18/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Nervous system disorders
presyncope
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.0%
3/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Tachypnea
|
12.0%
3/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Ecchymoses
|
16.0%
4/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
32.0%
8/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Weight gain
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
Weight loss
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.0%
2/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
|
Investigations
White blood cell decreased
|
56.0%
14/25 • Up to 30 days after discontinuation of study drugs.
Incidence of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place