Trial Outcomes & Findings for Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL) (NCT NCT00490776)
NCT ID: NCT00490776
Last Updated: 2021-08-18
Results Overview
ORR was defined as the percentage of participants with best overall response (OR) of complete response (CR) or partial response (PR) based on mSWAT score, (OR = CR + PR). mSWAT score represents the product of the percentage total body surface area (%TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: modified SWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Results posted on
2021-08-18
Participant Flow
A total of 9 participants were enrolled in the study at 8 investigative sites in the USA from 5 July 2007 to 15 June 2009. Recruitment was stopped on 15 June 2009 (early termination date) due to low prevalence of study population and slow accrual.
Participant milestones
| Measure |
Panobinostat 20 mg
Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
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|---|---|
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Overall Study
STARTED
|
9
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Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Panobinostat 20 mg
Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Administrative Problems
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
New Cancer Therapy
|
1
|
|
Overall Study
Disease Progression
|
5
|
Baseline Characteristics
Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
Baseline characteristics by cohort
| Measure |
Panobinostat 20 mg
n=9 Participants
Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
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|---|---|
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Age, Continuous
|
54.8 years
STANDARD_DEVIATION 13.29 • n=5 Participants
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Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to disease progression or death, (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
ORR was defined as the percentage of participants with best overall response (OR) of complete response (CR) or partial response (PR) based on mSWAT score, (OR = CR + PR). mSWAT score represents the product of the percentage total body surface area (%TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: modified SWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death, (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
Response rate was defined as the percentage of participants with CR or PR based on PGA scale. PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (Completely clear) on PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) on PGA scale and was defined as significant improvement (≥75% - \<90%); some evidence of disease remains.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death, (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
Response rate was defined as the percentage of participants with CR or PR based on mSWAT skin score. mSWAT score represents the product of the %TBSA involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: mSWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
Index lesions in each participant were selected as four to six of the prominent lesions amenable to bi-dimensional measurements. The longest diameter and its perpendicular measurement were used to determine the surface area and a weighted sum was determined as: Lesion 1 + lesion 2 + … + lesions 6 = Total sum of weighted score where Lesion 1: cm\^2 x \[1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)\]; Lesion 2: cm\^2 x \[1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)\]; Lesion 6: cm\^2 x \[1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)\]. These lesions were photographed at Baseline and at the time of response determined by either mSWAT or PGA
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death, (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
ORR was defined as the percentage of participants with best OR of CR or PR based on PGA scale (OR = CR + PR). The PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (completely clear) of PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) of PGA scale and was defined as significant improvement (≥75%-\<90%); some evidence of disease remains.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death, (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
DOR was defined as the time from first documented evidence of CR or PR until the earliest date of documented progression or death due to any cause among participants who achieved a confirmed CR or PR. The DOR was calculated in two ways. The DOR among responders only included participants who responded to the drug. The overall DOR included non-responders as having a DOR of zero days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to study completion (approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
TTR was defined as the time from the start of treatment until the first documented evidence of CR or PR among participants who achieved a confirmed CR or PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of study drug up to disease progression or death, (up to approximately 2 years)Population: Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study.
PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.
Outcome measures
Outcome data not reported
Adverse Events
Panobinostat 20 mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Panobinostat 20 mg
n=9 participants at risk
Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
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|---|---|
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Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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Infections and infestations
Sepsis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
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Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
Other adverse events
| Measure |
Panobinostat 20 mg
n=9 participants at risk
Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
3/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
55.6%
5/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Ear and labyrinth disorders
Ear pruritus
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Eye disorders
Eye irritation
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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|
Eye disorders
Lacrimation increased
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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|
Eye disorders
Vision blurred
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.6%
5/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Haematochezia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Asthenia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Fatigue
|
44.4%
4/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Gait disturbance
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Oedema peripheral
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Pain
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
General disorders
Thirst
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Hordeolum
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Oral candidiasis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Postoperative wound infection
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Staphylococcal skin infection
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Investigations
Lymph node palpable
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Investigations
Weight decreased
|
33.3%
3/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
3/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
3/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Renal and urinary disorders
Renal injury
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Vascular disorders
Lymphorrhoea
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER