Trial Outcomes & Findings for Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML (NCT NCT03466294)
NCT ID: NCT03466294
Last Updated: 2026-04-09
Results Overview
To determine the remission duration experienced by elderly previously untreated AML patients with azacitidine plus venetoclax followed by venetoclax alone as a maintenance therapy for patients who achieve a minimal residual disease (MRD) negative remission
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
From the first day a response is documented to the first day of disease progression
Results posted on
2026-04-09
Participant Flow
Participant milestones
| Measure |
Azacitidine and Venetoclax
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
Once a patient achieves a MRD negative composite response, they will enter the maintenance phase; azacitidine will be discontinued, and the dose of venetoclax will decrease from 600 mg daily to 400 mg daily if it has not already been reduced.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Azacitidine and Venetoclax
n=42 Participants
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
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|---|---|
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Age, Customized
60-100 years
|
42 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=42 Participants
|
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Sex: Female, Male
Male
|
21 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the first day a response is documented to the first day of disease progressionTo determine the remission duration experienced by elderly previously untreated AML patients with azacitidine plus venetoclax followed by venetoclax alone as a maintenance therapy for patients who achieve a minimal residual disease (MRD) negative remission
Outcome measures
| Measure |
Azacitidine and Venetoclax
n=42 Participants
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
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|---|---|
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Duration of Remission Response to Azacitidine and Venetoclax Treatment + Maintenance Therapy
|
12.9 months
Interval 7.4 to 17.6
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SECONDARY outcome
Timeframe: From Day 28, the first day a response is documented to end of cycle bone marrow biopsies, through 5 yearsTo determine the rate of MRD negative composite responses (includes complete remission \[CR\], complete remission with incomplete count recovery \[CRi\], and morphologic leukemia free state \[MLFS\]) with azacitidine plus venetoclax.
Outcome measures
| Measure |
Azacitidine and Venetoclax
n=28 Participants
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
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|---|---|
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Response Rate, With Responses Defined as Complete Remission (CR), Complete Remission With Incomplete Blood Count Recovery (CRi) and Morphologic Leukemia Free State (MLFS).
Overall response Rate (CR and CRi)
|
26 Participants
|
|
Response Rate, With Responses Defined as Complete Remission (CR), Complete Remission With Incomplete Blood Count Recovery (CRi) and Morphologic Leukemia Free State (MLFS).
MLFS
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 28, the first day a response is documented to end of cycle bone marrow biopsies, through 5 yearsMRD assessments by flow cytometry were employed for patients who achieved CR/CRI/MLFS. MRD-negative by this modality was defined as no evidence of aberrant myeloid antigen expression or abnormal myeloblasts at a level of detection \<0.1% in an adequate sample.
Outcome measures
| Measure |
Azacitidine and Venetoclax
n=28 Participants
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
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|---|---|
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MRD-Negativity Incidence
MRD negative by flow cytometry in patients with adequate samples
|
18 Participants
|
|
MRD-Negativity Incidence
Not MRD negative by flow cytometry in patients with adequate samples
|
10 Participants
|
SECONDARY outcome
Timeframe: From first dose of treatment to first day response is documented by bone marrow biopsy, on average 30 daysPopulation: Measured out of 18 patients achieving MRD negativity.
The median time to achieve MRD negative composite response
Outcome measures
| Measure |
Azacitidine and Venetoclax
n=18 Participants
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
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|---|---|
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To Determine the Median Time to Achieve a MRD Negative Composite Response
|
4 Weeks
Interval 1.0 to 12.0
|
Adverse Events
Azacitidine and Venetoclax
Serious events: 36 serious events
Other events: 42 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Azacitidine and Venetoclax
n=42 participants at risk
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.4%
1/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Bacteremia
|
7.1%
3/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders - Other, specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Cardiac Arrest
|
4.8%
2/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Encephalopathy
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
45.2%
19/42 • Number of events 26 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Flu Like Symptoms
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
General Disorders and Administration Site Conditions - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Hematoma
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Infections and Infestations - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Lung Infection
|
7.1%
3/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Myocardial Infarction
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and Mediastinal Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Sepsis
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Stroke
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Syncope
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Death NOS
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
Other adverse events
| Measure |
Azacitidine and Venetoclax
n=42 participants at risk
On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.
Azacitidine and Venetoclax: Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distention
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.0%
8/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
7.1%
3/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.5%
4/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Agitation
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
7/42 • Number of events 13 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Alkaline Phosphatase Increased
|
21.4%
9/42 • Number of events 15 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Anal Fissure
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Anemia
|
45.2%
19/42 • Number of events 54 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.2%
11/42 • Number of events 11 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Anosmia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Anxiety
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
5/42 • Number of events 5 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Ascites
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Aspartate Aminotransferase Increased
|
23.8%
10/42 • Number of events 16 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Atrial Fibrillation
|
9.5%
4/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
4/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Bacteremia
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Blood Bilirubin Increased
|
14.3%
6/42 • Number of events 12 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Blood Lactate Dehydrogenase
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Bronchial Infection
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Cardiac Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Cardiac Troponin I Increased
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Chills
|
19.0%
8/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Confusion
|
7.1%
3/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Constipation
|
54.8%
23/42 • Number of events 29 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
8/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Creatinine Increased
|
11.9%
5/42 • Number of events 9 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Delirium
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
22/42 • Number of events 31 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Dizziness
|
28.6%
12/42 • Number of events 12 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Eye disorders
Dry Eye
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Dysgeusia
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
9/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Ear and labyrinth disorders
Ear and Labyrinth Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Edema Limbs
|
28.6%
12/42 • Number of events 18 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Electrocardiogram QT corrected Interval Prolonged
|
7.1%
3/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.0%
8/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Eye disorders
Eye Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Injury, poisoning and procedural complications
Fall
|
11.9%
5/42 • Number of events 5 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Fatigue
|
38.1%
16/42 • Number of events 22 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
7/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Fever
|
21.4%
9/42 • Number of events 11 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Fibrinogen Decreased
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Eye disorders
Floaters
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Injury, poisoning and procedural complications
Fracture
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Fungemia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Gait Disturbance
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
General Disorders and Administration Site Conditions - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Generalized Edema
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Hallucinations
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Headache
|
23.8%
10/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Hematoma
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Herpes Simplex Reactivation
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Hot Flashes
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
2/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
3/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Hypertension
|
16.7%
7/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.9%
5/42 • Number of events 6 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.4%
9/42 • Number of events 11 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
14/42 • Number of events 24 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.0%
13/42 • Number of events 15 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
7/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
6/42 • Number of events 7 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.8%
10/42 • Number of events 24 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Hypotension
|
23.8%
10/42 • Number of events 13 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Hypothermia
|
2.4%
1/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
19.0%
8/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Ileus
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Immune system disorders
Immune System Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Infections and Infestations - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
INR Increased
|
16.7%
7/42 • Number of events 12 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Insomnia
|
14.3%
6/42 • Number of events 7 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Lethargy
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Lymphocyte Count Decreased
|
23.8%
10/42 • Number of events 23 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Malaise
|
9.5%
4/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Mitral Valve Disease
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Mucositis Oral
|
9.5%
4/42 • Number of events 5 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Muscle Cramp
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
2.4%
1/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.5%
4/42 • Number of events 7 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
21/42 • Number of events 26 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Nervous System Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Neutrophil Count Decreased
|
40.5%
17/42 • Number of events 41 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Non-Cardiac Chest Pain
|
9.5%
4/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Nystagmus
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Oral Pain
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Pain
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Platelet Count Decreased
|
57.1%
24/42 • Number of events 77 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
16.7%
7/42 • Number of events 8 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Hemorrhage
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.0%
8/42 • Number of events 10 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Product Issues
Psychiatric Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Psychiatric disorders
Psychiatric Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Nervous system disorders
Syncope
|
9.5%
4/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
7.1%
3/42 • Number of events 4 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Rash Pustular
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Rectal Pain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and Mediastinal Disorders - Other, Specify
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
General disorders
Rhinorrhea
|
14.3%
6/42 • Number of events 7 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Right Ventricle Dysfunction
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Infections and infestations
Sepsis
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Sinus Tachycardia
|
4.8%
2/42 • Number of events 2 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
23.8%
10/42 • Number of events 11 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Superficial Thrombophlebitis
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Surgical and medical procedures
Surgical and Medical Procedures - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Thromboembolic Event
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Cardiac disorders
Tricuspid Valve Disease
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.9%
5/42 • Number of events 6 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Urinary Frequency
|
7.1%
3/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Urinary Retention
|
4.8%
2/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
9.5%
4/42 • Number of events 7 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Renal and urinary disorders
Urine Output Decreased
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Vascular disorders
Vascular Disorders - Other, Specify
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
15/42 • Number of events 18 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Eye disorders
Watering eyes
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Weight Gain
|
2.4%
1/42 • Number of events 1 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
Weight Loss
|
19.0%
8/42 • Number of events 11 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.8%
2/42 • Number of events 3 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
|
Investigations
White Blood Cell Decreased
|
42.9%
18/42 • Number of events 58 • From the time the patient receives the first dose of study drug until 30 days after last study treatment, an average of 60 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place