Trial Outcomes & Findings for Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma (NCT NCT00742027)
NCT ID: NCT00742027
Last Updated: 2021-07-28
Results Overview
ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
From the start of the treatment of last participant up to 32 weeks
Results posted on
2021-07-28
Participant Flow
Participants were enrolled at 45 sites in 13 countries from 16 September 2008 to 12 August 2013.
A total of 102 participants were to be enrolled and treated in the study. However, 129 participants got enrolled and analyzed, out of which no participant completed the study.
Participant milestones
| Measure |
Panobinostat
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
129
|
Reasons for withdrawal
| Measure |
Panobinostat
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Overall Study
Disease Progression
|
76
|
|
Overall Study
New Cancer Therapy
|
19
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Death
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Follow up Phase Completed As Per Protocol
|
2
|
|
Overall Study
Missing
|
2
|
|
Overall Study
Administrative Problems
|
1
|
Baseline Characteristics
Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Panobinostat
n=129 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of the treatment of last participant up to 32 weeksPopulation: Full analysis set (FAS) included all participants who received at least one dose of study drug.
ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.
Outcome measures
| Measure |
Panobinostat
n=129 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
Complete Response
|
5 Participants
|
|
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
Partial Response
|
30 Participants
|
|
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
Stable Disease
|
71 Participants
|
|
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
Progressive Disease
|
14 Participants
|
|
Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria
Unknown
|
9 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years)Population: FAS included all participants who received at least one dose of study drug.
Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.
Outcome measures
| Measure |
Panobinostat
n=129 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
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|---|---|
|
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
Partial Response
|
20.9 percentage of participants
|
|
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
Stable Disease
|
56.6 percentage of participants
|
|
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
Progressive Disease
|
15.5 percentage of participants
|
|
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
Unknown
|
6.2 percentage of participants
|
|
Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)
Complete Response
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: From the start of treatment up to approximately 5 yearsPopulation: FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation.
Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment.
Outcome measures
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
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|---|---|
|
Time To Overall Disease Response in Responders
|
9.9 weeks
Interval 6.0 to 12.1
|
SECONDARY outcome
Timeframe: From the start of treatment up to approximately 5 yearsPopulation: FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation.
Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study.
Outcome measures
| Measure |
Panobinostat
n=35 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
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|---|---|
|
Duration of Overall Disease Response
|
30.1 weeks
Interval 17.4 to 35.9
|
SECONDARY outcome
Timeframe: From the start of treatment up to approximately 5 yearsPopulation: FAS included all participants who received at least one dose of study drug.
Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Panobinostat
n=129 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Progression Free Survival (PFS)
|
6.1 months
Interval 5.4 to 8.3
|
SECONDARY outcome
Timeframe: Baseline to date of death from any cause (up to approximately 5 years)Population: FAS included all participants who received at least one dose of study drug.
OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment.
Outcome measures
| Measure |
Panobinostat
n=129 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
The Overall Survival (OS)
|
34.9 months
Interval 0.7 to 53.0
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsPopulation: Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
Outcome measures
| Measure |
Panobinostat
n=129 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
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|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat
AEs
|
100 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat
SAEs
|
39.5 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat
Deaths
|
45.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dosePopulation: Pharmacokinetic set (PK) included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile.
Outcome measures
| Measure |
Panobinostat
n=13 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
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|---|---|
|
Maximum Observed Concentration (Cmax) of Panobinostat
|
41.88 nanograms per milliliter (ng/mL)
Standard Deviation 22.165
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dosePopulation: PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile.
Outcome measures
| Measure |
Panobinostat
n=13 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat
|
1.1 hours
Interval 0.3 to 6.1
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dosePopulation: PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile.
Outcome measures
| Measure |
Panobinostat
n=13 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat
|
233.38 hour*nanograms per milliliter (h.ng/mL)
Standard Deviation 112.138
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dosePopulation: PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. Overall number analyzed is the number of participants with data available for this analyses.
Outcome measures
| Measure |
Panobinostat
n=11 Participants
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat
|
239.36 h.ng/mL
Standard Deviation 104.263
|
Adverse Events
Panobinostat
Serious events: 51 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panobinostat
n=129 participants at risk
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
12/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Pericardial effusion
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Colitis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Multi-organ failure
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Appendicitis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Bronchopneumonia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Dengue fever
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Device related infection
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Device related sepsis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Infection
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Necrotising ulcerative gingivostomatitis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Sepsis
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Septic shock
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervicitis human papilloma virus
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Lethargy
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Nerve root compression
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Neuralgia
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Mental status changes
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.78%
1/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
2/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
Other adverse events
| Measure |
Panobinostat
n=129 participants at risk
Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.3%
52/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.4%
16/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.9%
36/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
84.5%
109/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Bradycardia
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Palpitations
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Endocrine disorders
Hypothyroidism
|
15.5%
20/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.2%
17/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.3%
21/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
19.4%
25/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
74.4%
96/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
10.9%
14/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
12/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
4.7%
6/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
67.4%
87/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
7.0%
9/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
42.6%
55/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Asthenia
|
18.6%
24/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Chills
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Fatigue
|
46.5%
60/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Influenza like illness
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Local swelling
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Non-cardiac chest pain
|
7.8%
10/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
13.2%
17/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
43.4%
56/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
General disorders
Thirst
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Bronchopneumonia
|
4.7%
6/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Cystitis
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Device related infection
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Ear infection
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Folliculitis
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Herpes zoster
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Influenza
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Lung infection
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Nail infection
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
12/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Oral candidiasis
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Oral herpes
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Rhinitis
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
7.0%
9/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.7%
19/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
6/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
4.7%
6/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
7.8%
10/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Blood potassium decreased
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Electrocardiogram T wave inversion
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Platelet count decreased
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Investigations
Weight decreased
|
12.4%
16/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.2%
48/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.7%
6/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.7%
19/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.6%
24/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.8%
10/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
23.3%
30/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.1%
13/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.9%
14/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
16.3%
21/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
20.9%
27/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Lethargy
|
7.0%
9/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Neuralgia
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Sinus headache
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Somnolence
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
Tremor
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Anxiety
|
12.4%
16/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
8.5%
11/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
9.3%
12/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
Dysuria
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.9%
36/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.8%
23/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.7%
6/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.6%
15/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
10/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.8%
10/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.4%
7/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
8/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.1%
13/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
3/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.1%
4/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.3%
12/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.3%
21/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
11/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Vascular disorders
Haematoma
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
3.9%
5/129 • Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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