Trial Outcomes & Findings for Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma (NCT NCT00445068)
NCT ID: NCT00445068
Last Updated: 2021-07-14
Results Overview
The response (complete response (CR) / partial response (PR)) rate as per Bladé criteria was assessed by the investigator. Response to treatment was evaluated in participants with multiple myeloma (MM) who have received at least two prior lines of therapy and whose disease was refractory to the most recent line of therapy.
TERMINATED
PHASE2
38 participants
From Start of the Study up to 57 Weeks approximately.
2021-07-14
Participant Flow
The study was conducted at 27 centers in 6 countries
A total 38 participants were enrolled in the study, of which 38 discontinued the study.
Participant milestones
| Measure |
Panobinostat
Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Panobinostat
Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Disease progression
|
26
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Abnormal laboratory value
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Panobinostat
n=38 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle.
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 6.58 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
31 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Pacific islander
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed in Full Analysis Set (FAS) population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated due to insufficient clinical efficacy in the targeted participants population. Due to insufficient data, this outcome could not be measured.
The response (complete response (CR) / partial response (PR)) rate as per Bladé criteria was assessed by the investigator. Response to treatment was evaluated in participants with multiple myeloma (MM) who have received at least two prior lines of therapy and whose disease was refractory to the most recent line of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated due to insufficient clinical efficacy in the targeted participants population. Due to insufficient data, this outcome could not be measured.
Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated due to insufficient clinical efficacy in the targeted participants population. Due to insufficient data, this outcome could not be measured.
Clinical benefit rate is defined by the percentage of participants achieving either a confirmed tumor response or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated due to insufficient clinical efficacy in the targeted participants population. Due to insufficient data, this outcome could not be measured.
Duration of response is defined as time between time to first documented response (CR/PR) and time to first documented disease progression or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated due to insufficient clinical efficacy in the targeted participants population. Due to insufficient data, this outcome could not be measured.
Time to response is defined as time between Day 1 cycle 1 and time to first documented response (CR/PR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated due to insufficient clinical efficacy in the targeted participants population. Due to insufficient data, this outcome could not be measured.
Progressions free survival is defined as time between Day 1 cycle 1 and time to first documented disease progression or death. Disease progression will be determined as per response criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Start of the Study up to 57 Weeks approximately.Population: The analysis was performed on Safety population consisted of all participants who had received at least one dose of study medication and had one valid post-baseline assessment.
Adverse Event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Outcome measures
| Measure |
Panobinostat
n=38 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Safety and Tolerability
Adverse Events Leading to discontinuation
|
8 Participants
|
|
Safety and Tolerability
Participants with Adverse Events
|
38 Participants
|
|
Safety and Tolerability
Deaths
|
7 Participants
|
|
Safety and Tolerability
On treatment deaths
|
3 Participants
|
|
Safety and Tolerability
Serious Adverse Events
|
17 Participants
|
|
Safety and Tolerability
Study-drug-related Serious Adverse Events
|
3 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8Population: The analysis was performed in Pharmacokinetic Analysis (PAS) population, defined as all participants who provide at least one post-dose Pharmacokinetic (PK) plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
Outcome measures
| Measure |
Panobinostat
n=27 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Peak Concentration (Tmax) of Panobinostat
Day 1
|
1.7 Hours
Interval 0.2 to 5.2
|
|
Time to Peak Concentration (Tmax) of Panobinostat
Day 8
|
1.2 Hours
Interval 0.2 to 23.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8Population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Outcome measures
| Measure |
Panobinostat
n=27 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Panobinostat
Day 1
|
7.6 ng/mL
Standard Deviation 5.52
|
|
Maximum Plasma Concentration (Cmax) of Panobinostat
Day 8
|
9.7 ng/mL
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8Population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.
Outcome measures
| Measure |
Panobinostat
n=27 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Area Under the Plasma Concentration (AUC0-24) of Panobinostat
Day 1
|
72.0 ng*hr/ml
Standard Deviation 36.10
|
|
Area Under the Plasma Concentration (AUC0-24) of Panobinostat
Day 8
|
81.6 ng*hr/ml
Standard Deviation 37.56
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8Population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
Outcome measures
| Measure |
Panobinostat
n=27 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Last Observed Plasma Concentration (Clast) of Panobinostat
Day 1
|
0.3 ng/mL
Standard Deviation 0.18
|
|
Last Observed Plasma Concentration (Clast) of Panobinostat
Day 8
|
1.1 ng/mL
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8Population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
Outcome measures
| Measure |
Panobinostat
n=27 Participants
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
|
|---|---|
|
Time of Clast (Tlast) of Panobinostat
Day 1
|
47.8 Hours
Interval 24.0 to 50.2
|
|
Time of Clast (Tlast) of Panobinostat
Day 8
|
24.3 Hours
Interval 3.3 to 28.0
|
Adverse Events
Panobinostat
Serious adverse events
| Measure |
Panobinostat
n=38 participants at risk
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Retching
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
General physical health deterioration
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Pain
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Infection
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Sepsis syndrome
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Streptococcal infection
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Monoclonal immunoglobulin present
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Somnolence
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Uraemic encephalopathy
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Emotional distress
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure acute
|
2.6%
1/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Panobinostat
n=38 participants at risk
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle.
|
|---|---|
|
General disorders
Gait disturbance
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
21.1%
8/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Pain
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
34.2%
13/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.2%
13/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.1%
16/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
13.2%
5/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.1%
16/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
52.6%
20/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
12/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Asthenia
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Fatigue
|
47.4%
18/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
21.1%
8/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastrointestinal infection
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Influenza
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
26.3%
10/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Blood uric acid increased
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Weight decreased
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.4%
7/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.8%
6/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.8%
14/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
21.1%
8/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Somnolence
|
10.5%
4/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure acute
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.7%
9/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
3/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • From Start of the Study up to 57 Weeks approximately.
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place