Trial Outcomes & Findings for A Study to Evaluate Safety and Efficacy of Panobinostat in Participants With Primary Myelofibrosis (NCT NCT00931762)
NCT ID: NCT00931762
Last Updated: 2021-07-30
Results Overview
Overall response (OR) = Complete remission (CR) + Partial remission (PR) + Clinical improvement (CI). CR: complete resolution of disease-related symptoms and signs with hemoglobin level 110 grams per deciliter (g/L), platelet count 100 x 10\^9/liter (L), and absolute neutrophil count (ANC) 1.0 x 10\^9/L, all 3 blood counts \< upper normal limit (UNL), normal leukocyte differential, and bone marrow histologic remission. PR= all of the criteria for CR except the requirement for bone marrow histologic remission. CI= minimum 20 g/L increase in hemoglobin for transfusion or becoming transfusion independent or reduction in splenomegaly ≥ 50% or 100% increase in platelet count and absolute platelet count of 50 x 10\^9/L and 100% increase in ANC of at least 0.5 x 10\^9/L.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to approximately 2 years
Results posted on
2021-07-30
Participant Flow
Participants were enrolled at 9 investigative centers in the United States from 31 August 2009 to 29 August 2011.
Participant milestones
| Measure |
Panobinostat
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
|
35
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Reasons for withdrawal
| Measure |
Panobinostat
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Overall Study
Abnormal Laboratory Value (s)
|
2
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|
Overall Study
Administrative Problems
|
5
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|
Overall Study
Death
|
1
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|
Overall Study
Disease Progression
|
3
|
|
Overall Study
Adverse Event (s)
|
11
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Overall Study
Subject withdrew consent
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13
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Baseline Characteristics
A Study to Evaluate Safety and Efficacy of Panobinostat in Participants With Primary Myelofibrosis
Baseline characteristics by cohort
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Age, Continuous
|
68.3 years
STANDARD_DEVIATION 10.30 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: FAS population included all participants who received at least one dose of study drug.
Overall response (OR) = Complete remission (CR) + Partial remission (PR) + Clinical improvement (CI). CR: complete resolution of disease-related symptoms and signs with hemoglobin level 110 grams per deciliter (g/L), platelet count 100 x 10\^9/liter (L), and absolute neutrophil count (ANC) 1.0 x 10\^9/L, all 3 blood counts \< upper normal limit (UNL), normal leukocyte differential, and bone marrow histologic remission. PR= all of the criteria for CR except the requirement for bone marrow histologic remission. CI= minimum 20 g/L increase in hemoglobin for transfusion or becoming transfusion independent or reduction in splenomegaly ≥ 50% or 100% increase in platelet count and absolute platelet count of 50 x 10\^9/L and 100% increase in ANC of at least 0.5 x 10\^9/L.
Outcome measures
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Overall Response (OR) Rate Per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria
|
2.9 percentage of participants
Interval 0.1 to 14.9
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SECONDARY outcome
Timeframe: Baseline, Cycle 6 (each cycle was of 28 days)Population: FAS population included all participants who received at least one dose of study drug. All 35 participants were evaluated for this Outcome. The Number Analyzed represented in each row differs from the Overall Number of Participants Analyzed as scores that are presented are for the participants who reported the measured event at the time evaluated.
The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions were scored on a scale of 0-10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1-6 investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asked participants to report levels of inactivity. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Fatigue Right now
|
-1.5 score on a scale
Standard Deviation 2.12
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Fatigue Usual Past 24 Hours
|
-1.0 score on a scale
Standard Deviation 5.66
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Fatigue Worst Past 24 Hours
|
-3.0 score on a scale
Standard Deviation 2.83
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Mood
|
-3.5 score on a scale
Standard Deviation 3.54
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Normal Work
|
-4.0 score on a scale
Standard Deviation 4.24
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Relations with Other People
|
-4.5 score on a scale
Standard Deviation 2.12
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Filling up quickly when you eat
|
1.0 score on a scale
Standard Deviation 1.41
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Abdominal pain or Discomfort
|
0.5 score on a scale
Standard Deviation 2.12
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Inactivity
|
-0.5 score on a scale
Standard Deviation 3.54
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Cough
|
-1.5 score on a scale
Standard Deviation 2.12
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Night Sweats
|
-0.5 score on a scale
Standard Deviation 0.71
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Itching
|
1.5 score on a scale
Standard Deviation 2.12
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Bone Pain
|
-2.5 score on a scale
Standard Deviation 0.71
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: General Activity
|
-3.5 score on a scale
Standard Deviation 2.12
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Walking Ability
|
-3.0 score on a scale
Standard Deviation 5.66
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: Enjoyment of Life
|
-5.0 score on a scale
Standard Deviation 4.24
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores At Cycle 6
Cycle 6, Day 1: What is Overall Quality of Life?
|
-2.5 score on a scale
Standard Deviation 2.12
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SECONDARY outcome
Timeframe: Baseline, Cycles 2, and 4 (each cycle was of 28-days)Population: FAS population included all participants who received at least one dose of study drug. All 35 participants were evaluated for this Outcome. The Number Analyzed represented in each row differs from the Overall Number of Participants Analyzed as scores that are presented are for the participants who reported the measured event at the time evaluated.
The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions were scored on a scale of 0-10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1-6 investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asked participants to report levels of inactivity. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
|
|---|---|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Fatigue Right now
|
0.0 score on a scale
Standard Deviation 2.00
|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Fatigue Usual Past 24 Hours
|
0.5 score on a scale
Standard Deviation 1.83
|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Fatigue Worst Past 24 Hours
|
0.7 score on a scale
Standard Deviation 1.98
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: General Activity
|
0.0 score on a scale
Standard Deviation 2.03
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Mood
|
0.5 score on a scale
Standard Deviation 2.15
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Walking Ability
|
-0.6 score on a scale
Standard Deviation 2.86
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Normal Work
|
0.2 score on a scale
Standard Deviation 2.87
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Enjoyment of Life
|
0.3 score on a scale
Standard Deviation 3.30
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Filling up quickly when you eat
|
0.7 score on a scale
Standard Deviation 2.38
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Abdominal Pain or Discomfort
|
-0.0 score on a scale
Standard Deviation 2.64
|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Inactivity
|
0.8 score on a scale
Standard Deviation 2.45
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Cough
|
-0.1 score on a scale
Standard Deviation 2.07
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Night Sweats
|
-1.0 score on a scale
Standard Deviation 2.36
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Itching
|
-1.5 score on a scale
Standard Deviation 2.89
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Bone Pain
|
-1.0 score on a scale
Standard Deviation 2.79
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: What is Overall Quality of Life?
|
-0.4 score on a scale
Standard Deviation 2.24
|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Fatigue Right now
|
0.0 score on a scale
Standard Deviation 1.93
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Fatigue Usual Past 24 Hours
|
0.8 score on a scale
Standard Deviation 1.91
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Fatigue Worst Past 24 Hours
|
1.0 score on a scale
Standard Deviation 1.31
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: General Activity
|
-0.5 score on a scale
Standard Deviation 3.07
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Mood
|
0.3 score on a scale
Standard Deviation 2.75
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Walking Ability
|
-0.6 score on a scale
Standard Deviation 3.26
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Normal Work
|
0.9 score on a scale
Standard Deviation 2.53
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Relations with Other People
|
-0.6 score on a scale
Standard Deviation 2.20
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Enjoyment of Life
|
0.4 score on a scale
Standard Deviation 3.62
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Abdominal Pain or Discomfort
|
1.0 score on a scale
Standard Deviation 2.67
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Inactivity
|
0.6 score on a scale
Standard Deviation 3.25
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Cough
|
-0.9 score on a scale
Standard Deviation 1.36
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Night Sweats
|
-1.1 score on a scale
Standard Deviation 3.52
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Itching
|
-0.1 score on a scale
Standard Deviation 0.90
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|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Bone Pain
|
-1.8 score on a scale
Standard Deviation 3.41
|
|
Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: What is Overall Quality of Life?
|
-0.3 score on a scale
Standard Deviation 1.60
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 2, Day 1: Relations with Other People
|
-0.1 score on a scale
Standard Deviation 2.71
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Change From Baseline in Myelofibrosis Symptom Assessment Form (MF-SAF) Scale Scores
Cycle 4, Day 1: Filling up quickly when you eat
|
-0.1 score on a scale
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)Population: Safety set population included all participants who received at least one dose of study drug and had at least one post-baseline safety assessment.
An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. SAEs was an undesirable sign, symptom or medical condition which is: life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, requires hospitalizations or prolongation of hospitalizations, or is medically significant
Outcome measures
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs)
AEs
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35 Participants
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Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs)
SAEs
|
19 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 yearsOutcome measures
Outcome data not reported
Adverse Events
Panobinostat
Serious events: 19 serious events
Other events: 35 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Panobinostat
n=35 participants at risk
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
7/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Arterial haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Panobinostat
n=35 participants at risk
Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
10/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.1%
6/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
51.4%
18/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Endocrine disorders
Cushingoid
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Eye haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
17.1%
6/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
7/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
22.9%
8/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
77.1%
27/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
7/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faecal incontinence
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
54.3%
19/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
37.1%
13/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Adverse drug reaction
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chills
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
57.1%
20/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Feeling jittery
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
17.1%
6/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pain
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
17.1%
6/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Candidiasis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Furuncle
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Vitamin D decreased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
54.3%
19/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
17.1%
6/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
20.0%
7/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
7/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
14.3%
5/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
7/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.4%
4/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.6%
3/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.7%
2/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
1/35 • AE: From the start of treatment up to 28 days after last study dose (up to approximately 2 years); SAE: From time of informed consent up to 4 weeks after last study dose (approximately 2 years)
Safety set population included all participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER