Trial Outcomes & Findings for Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy (NCT NCT00702052)
NCT ID: NCT00702052
Last Updated: 2021-05-25
Results Overview
Overall response rate was defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in the sum of the product of diameter (SPD) of all index nodal and extranodal lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
From date of enrollment up to disease progression or death (approximately 3.8 years)
Results posted on
2021-05-25
Participant Flow
Participants took part in the study at 26 investigative sites in the United States from 22 August 2008 to 20 April 2012.
Participant milestones
| Measure |
Everolimus
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
| Measure |
Everolimus
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Overall Study
Adverse Event
|
23
|
|
Overall Study
Disease Progression
|
30
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy
Baseline characteristics by cohort
| Measure |
Everolimus
n=58 Participants
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Age, Continuous
|
66.29 years
STANDARD_DEVIATION 7.991 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment up to disease progression or death (approximately 3.8 years)Population: The Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.
Overall response rate was defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in the sum of the product of diameter (SPD) of all index nodal and extranodal lesions.
Outcome measures
| Measure |
Everolimus
n=58 Participants
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Overall Response Rate (ORR)
|
8.6 percentage of participants
Interval 3.5 to 17.3
|
SECONDARY outcome
Timeframe: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)Population: The FAS included all participants who received at least one dose of the study drug.
Disease Control Rate was defined as the percentage of participants with best overall disease response of CR or PR or stable disease (SD). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in SPD of all index nodal and extranodal lesions. SD was defined failure to attain the criteria needed for CR or PR and failure to fulfill the criteria for at least a 50% increase in the SPD of all index nodal and extranodal (including splenic and/or hepatic nodules) lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline.
Outcome measures
| Measure |
Everolimus
n=58 Participants
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Disease Control Rate (DCR)
|
69.0 percentage of participants
Interval 57.5 to 78.9
|
SECONDARY outcome
Timeframe: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)Population: We have exhausted all efforts to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure.
Duration of response 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. CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in SPD of all index nodal and extranodal lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)Population: The FAS included all participants who received at least one dose of the study drug.
PFS was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause.
Outcome measures
| Measure |
Everolimus
n=58 Participants
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.40 months
Interval 3.48 to 6.08
|
SECONDARY outcome
Timeframe: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)Population: The FAS included all participants who received at least one dose of the study drug.
Overall survival was defined as the time from the date of start of study treatment to the date of death due to any cause.
Outcome measures
| Measure |
Everolimus
n=58 Participants
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Overall Survival
|
16.85 months
Interval 14.36 to 29.86
|
SECONDARY outcome
Timeframe: From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)Population: The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
Outcome measures
| Measure |
Everolimus
n=58 Participants
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Number of Participants With At Least One Adverse Event (AE) and Serious Adverse Event (SAE)
SAE
|
29 Participants
|
|
Number of Participants With At Least One Adverse Event (AE) and Serious Adverse Event (SAE)
AE
|
58 Participants
|
Adverse Events
Everolimus
Serious events: 29 serious events
Other events: 58 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Everolimus
n=58 participants at risk
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
2/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Cardiac disorders
Intracardiac thrombus
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Asthenia
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Multi-organ failure
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Immune system disorders
Drug hypersensitivity
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Arthritis infective
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Cellulitis
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Clostridial infection
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Diverticulitis
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Pneumonia
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Nervous system disorders
Hydrocephalus
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Psychiatric disorders
Mental status changes
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Vascular disorders
Venous thrombosis limb
|
1.7%
1/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
Other adverse events
| Measure |
Everolimus
n=58 participants at risk
Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.1%
7/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.9%
15/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
29.3%
17/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Cardiac disorders
Tachycardia
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Eye disorders
Lacrimation increased
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Eye disorders
Vision blurred
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
11/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Constipation
|
15.5%
9/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.8%
26/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
12.1%
7/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.6%
5/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Nausea
|
27.6%
16/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Oral pain
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Proctalgia
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
20.7%
12/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Toothache
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
10/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Asthenia
|
13.8%
8/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Fatigue
|
43.1%
25/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Oedema peripheral
|
27.6%
16/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Pain
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
General disorders
Pyrexia
|
20.7%
12/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Bronchitis
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Candidiasis
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Herpes zoster
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Pneumonia
|
8.6%
5/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Sinusitis
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
7/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Investigations
Blood triglycerides increased
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Investigations
Platelet count decreased
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Investigations
Weight decreased
|
13.8%
8/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.4%
13/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
5/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.6%
5/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.8%
8/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.5%
9/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
5/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Nervous system disorders
Dizziness
|
15.5%
9/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Nervous system disorders
Dysgeusia
|
13.8%
8/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Nervous system disorders
Headache
|
19.0%
11/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Psychiatric disorders
Depression
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Psychiatric disorders
Insomnia
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.7%
12/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.7%
12/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.1%
7/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.3%
6/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.2%
3/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
5/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
4/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a valid post-baseline assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.6%
16/58 • From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
The safety set included all participants who received at least one dose of the study drug with a 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