Trial Outcomes & Findings for Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment. (NCT NCT01022996)
NCT ID: NCT01022996
Last Updated: 2016-05-18
Results Overview
ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal \& extranodal lesions: Radiological regression to normal size of all lymph nodes \& nodal masses \& complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal \& extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal \& extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented \& one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Results posted on
2016-05-18
Participant Flow
Participant milestones
| Measure |
RAD001
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
RAD001
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Administrative problems
|
6
|
|
Overall Study
Disease Progression
|
32
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Baseline characteristics by cohort
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Age, Continuous
|
36.33 years
STANDARD_DEVIATION 14.101 • n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reasonPopulation: Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.
ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal \& extranodal lesions: Radiological regression to normal size of all lymph nodes \& nodal masses \& complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal \& extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal \& extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented \& one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.
Outcome measures
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Overall Response Rate (ORR) Based on the Assessments by Investigator
Complete response (CR)
|
8.8 percentage of participants
|
|
Overall Response Rate (ORR) Based on the Assessments by Investigator
Partial response (PR)
|
36.8 percentage of participants
|
|
Overall Response Rate (ORR) Based on the Assessments by Investigator
Response of CR or PR
|
45.6 percentage of participants
|
SECONDARY outcome
Timeframe: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reasonPopulation: Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.
Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.
Outcome measures
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Time to Overall Response (TTR) Per Kaplan-Meier Estimate
|
NA Days
Interval 79.0 to
N/A = Not achieved
|
SECONDARY outcome
Timeframe: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reasonPopulation: Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.
The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.
Outcome measures
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Duration of Overall Response (DoR)
|
350.8 Days
Standard Deviation 388.63
|
SECONDARY outcome
Timeframe: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reasonPopulation: Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.
The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).
Outcome measures
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Disease Control Rate (DCR)
|
80.7 Percentage of participants
Interval 68.09 to 89.95
|
SECONDARY outcome
Timeframe: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reasonPopulation: Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.
The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.
Outcome measures
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Duration of Disease Control
|
321.9 Days
Standard Deviation 394.92
|
SECONDARY outcome
Timeframe: Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reasonPopulation: Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.
Progression-free survival (PFS) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.
Outcome measures
| Measure |
RAD001
n=57 Participants
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Progression Free Survival (PFS) by Kaplan-Meier Estimate
|
8.0 Days
Interval 5.07 to 10.96
|
Adverse Events
RAD001
Serious events: 18 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001
n=57 participants at risk
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
2/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
1/57
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/57
|
|
Cardiac disorders
Myocarditis
|
1.8%
1/57
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
1/57
|
|
Cardiac disorders
Tachycardia
|
3.5%
2/57
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/57
|
|
General disorders
Drug ineffective
|
1.8%
1/57
|
|
General disorders
Pain
|
1.8%
1/57
|
|
General disorders
Pyrexia
|
5.3%
3/57
|
|
Infections and infestations
Influenza
|
1.8%
1/57
|
|
Infections and infestations
Pneumonia
|
7.0%
4/57
|
|
Infections and infestations
Pseudomembranous colitis
|
1.8%
1/57
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
1/57
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.8%
1/57
|
|
Investigations
Haemoglobin decreased
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
1.8%
1/57
|
|
Nervous system disorders
Complex regional pain syndrome
|
1.8%
1/57
|
|
Nervous system disorders
Nerve compression
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.8%
1/57
|
|
Vascular disorders
Hypotension
|
3.5%
2/57
|
|
Vascular disorders
Subclavian artery occlusion
|
1.8%
1/57
|
Other adverse events
| Measure |
RAD001
n=57 participants at risk
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.6%
18/57
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.0%
8/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
47.4%
27/57
|
|
Eye disorders
Vision blurred
|
7.0%
4/57
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
3/57
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
9/57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
4/57
|
|
Gastrointestinal disorders
Constipation
|
8.8%
5/57
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
15/57
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
5/57
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.0%
4/57
|
|
Gastrointestinal disorders
Nausea
|
24.6%
14/57
|
|
Gastrointestinal disorders
Stomatitis
|
24.6%
14/57
|
|
Gastrointestinal disorders
Toothache
|
5.3%
3/57
|
|
Gastrointestinal disorders
Vomiting
|
22.8%
13/57
|
|
General disorders
Chest discomfort
|
7.0%
4/57
|
|
General disorders
Chest pain
|
10.5%
6/57
|
|
General disorders
Chills
|
8.8%
5/57
|
|
General disorders
Fatigue
|
57.9%
33/57
|
|
General disorders
Localised oedema
|
5.3%
3/57
|
|
General disorders
Malaise
|
5.3%
3/57
|
|
General disorders
Mucosal inflammation
|
8.8%
5/57
|
|
General disorders
Oedema peripheral
|
21.1%
12/57
|
|
General disorders
Pain
|
12.3%
7/57
|
|
General disorders
Peripheral swelling
|
5.3%
3/57
|
|
General disorders
Pyrexia
|
31.6%
18/57
|
|
Infections and infestations
Bronchitis
|
12.3%
7/57
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
5/57
|
|
Infections and infestations
Oral herpes
|
5.3%
3/57
|
|
Infections and infestations
Pneumonia
|
7.0%
4/57
|
|
Infections and infestations
Rhinitis
|
7.0%
4/57
|
|
Infections and infestations
Sinusitis
|
17.5%
10/57
|
|
Infections and infestations
Upper respiratory tract infection
|
24.6%
14/57
|
|
Infections and infestations
Urinary tract infection
|
7.0%
4/57
|
|
Injury, poisoning and procedural complications
Contusion
|
7.0%
4/57
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
8/57
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
9/57
|
|
Investigations
Blood alkaline phosphatase increased
|
15.8%
9/57
|
|
Investigations
Blood cholesterol increased
|
5.3%
3/57
|
|
Investigations
Blood glucose increased
|
5.3%
3/57
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.5%
6/57
|
|
Investigations
Liver function test abnormal
|
5.3%
3/57
|
|
Investigations
Weight decreased
|
12.3%
7/57
|
|
Investigations
White blood cell count decreased
|
5.3%
3/57
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.3%
7/57
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
10.5%
6/57
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.5%
10/57
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.3%
7/57
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
3/57
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.5%
6/57
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.3%
7/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
9/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.3%
15/57
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.8%
9/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.8%
5/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.8%
5/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
8/57
|
|
Nervous system disorders
Dysgeusia
|
14.0%
8/57
|
|
Nervous system disorders
Headache
|
22.8%
13/57
|
|
Nervous system disorders
Neuropathy peripheral
|
15.8%
9/57
|
|
Psychiatric disorders
Anxiety
|
5.3%
3/57
|
|
Psychiatric disorders
Depression
|
5.3%
3/57
|
|
Psychiatric disorders
Insomnia
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.4%
27/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.8%
17/57
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.0%
8/57
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.3%
3/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
19.3%
11/57
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
3/57
|
|
Skin and subcutaneous tissue disorders
Acne
|
14.0%
8/57
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.5%
6/57
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.1%
12/57
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.6%
22/57
|
|
Vascular disorders
Hot flush
|
5.3%
3/57
|
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