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Trial Outcomes & Findings for Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR) (NCT NCT00760877)

NCT ID: NCT00760877

Last Updated: 2016-11-08

Results Overview

The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity \>4.5 logs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

207 participants

Primary outcome timeframe

12 months

Results posted on

2016-11-08

Participant Flow

Participants were randomized 1:1. Participants in the imatinib arm were permitted to cross-over to nilotinib after 2 years on study if complete molecular response (CMR) was not achieved, or at any time during the study if participants experienced treatment failure, had confirmed loss of major molecular response (MMR) or had confirmed loss of CMR.

Participant milestones

Participant milestones
Measure
Nilotinib
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Overall Study
STARTED
104
103
Overall Study
Cross-over to Nilotinib
0
46
Overall Study
Safety Set
101
103
Overall Study
COMPLETED
59
77
Overall Study
NOT COMPLETED
45
26

Reasons for withdrawal

Reasons for withdrawal
Measure
Nilotinib
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Overall Study
Protocol Violation
1
0
Overall Study
Non-compliance with protocol treatment
2
1
Overall Study
Pregnancy
1
4
Overall Study
Death
2
1
Overall Study
Withdrawal by Subject
7
3
Overall Study
Adverse Event
19
12
Overall Study
Participant diagnosed with AML
0
1
Overall Study
Participant not eligible to cross-over
0
1
Overall Study
Physician Decision
1
2
Overall Study
Participants transferred to AMN107A2408
11
1
Overall Study
Treatment failure
1
0

Baseline Characteristics

Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nilotinib
n=104 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
n=103 Participants
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Total
n=207 Participants
Total of all reporting groups
Age, Continuous
48.3 Years
STANDARD_DEVIATION 13.26 • n=5 Participants
49.9 Years
STANDARD_DEVIATION 13.07 • n=7 Participants
49.1 Years
STANDARD_DEVIATION 13.16 • n=5 Participants
Sex: Female, Male
Female
33 Participants
n=5 Participants
38 Participants
n=7 Participants
71 Participants
n=5 Participants
Sex: Female, Male
Male
71 Participants
n=5 Participants
65 Participants
n=7 Participants
136 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The intent-to-treat analysis set, which included all randomized participants, was analyzed.

The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity \>4.5 logs.

Outcome measures

Outcome measures
Measure
Nilotinib
n=104 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
n=103 Participants
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)
Responders
13 Participants
6 Participants
Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)
Non-responders
91 Participants
97 Participants

SECONDARY outcome

Timeframe: 24 months, 36 month, 48 months

Population: The intent-to-treat analysis set, which included all randomized participants, was analyzed.

The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity \>4.5 logs.

Outcome measures

Outcome measures
Measure
Nilotinib
n=104 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
n=103 Participants
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Rate of Confirmed Best Cumulative CMR
24 months, Responders
24 Participants
11 Participants
Rate of Confirmed Best Cumulative CMR
24 months, Non-responders
80 Participants
92 Participants
Rate of Confirmed Best Cumulative CMR
36 months, Responders
29 Participants
21 Participants
Rate of Confirmed Best Cumulative CMR
36 months, Non-responders
75 Participants
82 Participants
Rate of Confirmed Best Cumulative CMR
48 months, Responders
32 Participants
21 Participants
Rate of Confirmed Best Cumulative CMR
48 months, Non-responders
72 Participants
82 Participants

SECONDARY outcome

Timeframe: 24 months, 36 months, 48 months

Population: Participants from the Imatinib treatment group who crossed over to the Nilotinib treatment group were analyzed.

The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity \>4.5 logs.

Outcome measures

Outcome measures
Measure
Nilotinib
n=46 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Number of Cross-over Participants With CMR
24 months
3 Participants
—
Number of Cross-over Participants With CMR
36 months
6 Participants
—
Number of Cross-over Participants With CMR
48 months
9 Participants
—

SECONDARY outcome

Timeframe: 48 months

Population: 24 months, Non-responders

PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.

Outcome measures

Outcome measures
Measure
Nilotinib
n=104 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
n=103 Participants
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Progression Free Survival (PFS)
NA months
The median and 95% confidence interval (CI) could not be calculated because there were too few events.
NA months
The median and 95% CI could not be calculated because there were too few events.

SECONDARY outcome

Timeframe: 48 months

Population: The intent-to-treat analysis set, which included all randomized participants, was analyzed.

Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.

Outcome measures

Outcome measures
Measure
Nilotinib
n=104 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
n=103 Participants
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Event-free Survival
NA Months
The median and 95% CI could not be calculated because there were too few events.
NA Months
The median and 95% CI could not be calculated because there were too few events.

SECONDARY outcome

Timeframe: 48 months

Population: The intent-to-treat analysis set, which included all randomized participants, was analyzed.

Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.

Outcome measures

Outcome measures
Measure
Nilotinib
n=104 Participants
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Imatinib
n=103 Participants
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Overall Survival
NA Months
The median and 95% CI could not be calculated because there were too few events.
NA Months
The median and 95% CI could not be calculated because there were too few events.

Adverse Events

Nilotinib

Serious events: 21 serious events
Other events: 99 other events
Deaths: 0 deaths

Imatinib

Serious events: 16 serious events
Other events: 79 other events
Deaths: 0 deaths

Imatinib Subset That Crossed Over to Nilotinib

Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Nilotinib
n=101 participants at risk
Nilotinib
Imatinib
n=103 participants at risk
Imatinib
Imatinib Subset That Crossed Over to Nilotinib
n=46 participants at risk
Imatinib subset that crossed over to nilotinib
Cardiac disorders
ACUTE CORONARY SYNDROME
0.99%
1/101
0.00%
0/103
2.2%
1/46
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
0.99%
1/101
0.00%
0/103
0.00%
0/46
Cardiac disorders
ATRIAL FIBRILLATION
0.99%
1/101
1.9%
2/103
0.00%
0/46
Cardiac disorders
ATRIAL FLUTTER
0.00%
0/101
0.00%
0/103
2.2%
1/46
Cardiac disorders
CARDIOPULMONARY FAILURE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Cardiac disorders
CORONARY ARTERY DISEASE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
0.00%
0/101
0.97%
1/103
0.00%
0/46
Cardiac disorders
MYOCARDIAL INFARCTION
0.00%
0/101
0.97%
1/103
0.00%
0/46
Cardiac disorders
PERICARDITIS
0.00%
0/101
0.97%
1/103
0.00%
0/46
Gastrointestinal disorders
ABDOMINAL PAIN
0.99%
1/101
0.00%
0/103
0.00%
0/46
Gastrointestinal disorders
ANAL FISSURE
0.00%
0/101
0.00%
0/103
2.2%
1/46
Gastrointestinal disorders
CROHN'S DISEASE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Gastrointestinal disorders
INGUINAL HERNIA
0.00%
0/101
0.97%
1/103
0.00%
0/46
General disorders
INFLUENZA LIKE ILLNESS
0.99%
1/101
0.00%
0/103
0.00%
0/46
General disorders
PYREXIA
0.00%
0/101
0.00%
0/103
2.2%
1/46
Hepatobiliary disorders
CHOLECYSTITIS
0.00%
0/101
0.00%
0/103
2.2%
1/46
Hepatobiliary disorders
CHOLELITHIASIS
0.99%
1/101
0.97%
1/103
0.00%
0/46
Infections and infestations
CELLULITIS
0.00%
0/101
1.9%
2/103
0.00%
0/46
Infections and infestations
ERYSIPELAS
0.99%
1/101
0.00%
0/103
0.00%
0/46
Infections and infestations
INFECTED SKIN ULCER
0.99%
1/101
0.00%
0/103
0.00%
0/46
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
0.99%
1/101
0.00%
0/103
0.00%
0/46
Infections and infestations
LUNG INFECTION
0.00%
0/101
0.97%
1/103
0.00%
0/46
Infections and infestations
OSTEOMYELITIS
0.99%
1/101
0.00%
0/103
0.00%
0/46
Infections and infestations
PNEUMONIA
0.00%
0/101
0.97%
1/103
2.2%
1/46
Injury, poisoning and procedural complications
ANKLE FRACTURE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Injury, poisoning and procedural complications
BACK INJURY
0.00%
0/101
0.00%
0/103
2.2%
1/46
Injury, poisoning and procedural complications
DRUG ADMINISTRATION ERROR
0.00%
0/101
0.00%
0/103
2.2%
1/46
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Injury, poisoning and procedural complications
MUSCLE INJURY
0.99%
1/101
0.00%
0/103
0.00%
0/46
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
0.00%
0/101
0.00%
0/103
2.2%
1/46
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
0.99%
1/101
0.00%
0/103
0.00%
0/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
0.00%
0/101
0.97%
1/103
0.00%
0/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
0.99%
1/101
0.00%
0/103
0.00%
0/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
0.00%
0/101
0.97%
1/103
0.00%
0/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER METASTATIC
0.00%
0/101
0.97%
1/103
0.00%
0/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
0.00%
0/101
1.9%
2/103
0.00%
0/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
0.99%
1/101
0.00%
0/103
0.00%
0/46
Nervous system disorders
CEREBRAL ARTERY OCCLUSION
0.99%
1/101
0.00%
0/103
0.00%
0/46
Nervous system disorders
CEREBRAL ISCHAEMIA
0.99%
1/101
0.00%
0/103
0.00%
0/46
Nervous system disorders
CEREBROVASCULAR ACCIDENT
0.99%
1/101
0.00%
0/103
2.2%
1/46
Nervous system disorders
EMBOLIC STROKE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Renal and urinary disorders
BLADDER DILATATION
0.99%
1/101
0.00%
0/103
0.00%
0/46
Renal and urinary disorders
NEPHROLITHIASIS
0.00%
0/101
1.9%
2/103
0.00%
0/46
Renal and urinary disorders
URINARY RETENTION
0.00%
0/101
0.97%
1/103
0.00%
0/46
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
0.99%
1/101
0.00%
0/103
0.00%
0/46
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
0.00%
0/101
1.9%
2/103
0.00%
0/46
Vascular disorders
DEEP VEIN THROMBOSIS
0.00%
0/101
0.97%
1/103
0.00%
0/46
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
0.99%
1/101
0.00%
0/103
0.00%
0/46
Vascular disorders
PERIPHERAL VASCULAR DISORDER
0.00%
0/101
0.00%
0/103
2.2%
1/46
Vascular disorders
VASCULITIS
0.99%
1/101
0.00%
0/103
0.00%
0/46

Other adverse events

Other adverse events
Measure
Nilotinib
n=101 participants at risk
Nilotinib
Imatinib
n=103 participants at risk
Imatinib
Imatinib Subset That Crossed Over to Nilotinib
n=46 participants at risk
Imatinib subset that crossed over to nilotinib
Blood and lymphatic system disorders
ANAEMIA
5.9%
6/101
11.7%
12/103
10.9%
5/46
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
0.99%
1/101
5.8%
6/103
0.00%
0/46
Gastrointestinal disorders
ABDOMINAL PAIN
11.9%
12/101
7.8%
8/103
10.9%
5/46
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
12.9%
13/101
6.8%
7/103
10.9%
5/46
Gastrointestinal disorders
CONSTIPATION
14.9%
15/101
0.00%
0/103
6.5%
3/46
Gastrointestinal disorders
DIARRHOEA
13.9%
14/101
18.4%
19/103
8.7%
4/46
Gastrointestinal disorders
NAUSEA
21.8%
22/101
15.5%
16/103
8.7%
4/46
Gastrointestinal disorders
VOMITING
10.9%
11/101
5.8%
6/103
0.00%
0/46
General disorders
ASTHENIA
8.9%
9/101
3.9%
4/103
10.9%
5/46
General disorders
FATIGUE
15.8%
16/101
7.8%
8/103
13.0%
6/46
General disorders
INFLUENZA LIKE ILLNESS
6.9%
7/101
2.9%
3/103
4.3%
2/46
General disorders
OEDEMA PERIPHERAL
5.9%
6/101
6.8%
7/103
2.2%
1/46
General disorders
PAIN
6.9%
7/101
2.9%
3/103
2.2%
1/46
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
9.9%
10/101
0.00%
0/103
13.0%
6/46
Infections and infestations
FOLLICULITIS
7.9%
8/101
0.00%
0/103
4.3%
2/46
Infections and infestations
INFLUENZA
8.9%
9/101
8.7%
9/103
4.3%
2/46
Infections and infestations
NASOPHARYNGITIS
8.9%
9/101
4.9%
5/103
4.3%
2/46
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
19.8%
20/101
13.6%
14/103
15.2%
7/46
Infections and infestations
URINARY TRACT INFECTION
7.9%
8/101
0.97%
1/103
4.3%
2/46
Investigations
ALANINE AMINOTRANSFERASE INCREASED
18.8%
19/101
4.9%
5/103
17.4%
8/46
Investigations
AMYLASE INCREASED
8.9%
9/101
6.8%
7/103
4.3%
2/46
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
13.9%
14/101
9.7%
10/103
13.0%
6/46
Investigations
BILIRUBIN CONJUGATED INCREASED
4.0%
4/101
0.00%
0/103
8.7%
4/46
Investigations
BLOOD BILIRUBIN INCREASED
9.9%
10/101
0.97%
1/103
4.3%
2/46
Investigations
BLOOD CHOLESTEROL INCREASED
7.9%
8/101
1.9%
2/103
0.00%
0/46
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
0.99%
1/101
8.7%
9/103
4.3%
2/46
Investigations
BLOOD CREATININE INCREASED
5.9%
6/101
9.7%
10/103
4.3%
2/46
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
7.9%
8/101
1.9%
2/103
4.3%
2/46
Investigations
GLOBULINS DECREASED
4.0%
4/101
7.8%
8/103
0.00%
0/46
Investigations
HIGH DENSITY LIPOPROTEIN DECREASED
2.0%
2/101
5.8%
6/103
6.5%
3/46
Investigations
LIPASE INCREASED
18.8%
19/101
12.6%
13/103
15.2%
7/46
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
2.0%
2/101
2.9%
3/103
8.7%
4/46
Investigations
WEIGHT DECREASED
9.9%
10/101
4.9%
5/103
4.3%
2/46
Metabolism and nutrition disorders
DECREASED APPETITE
7.9%
8/101
5.8%
6/103
2.2%
1/46
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
10.9%
11/101
5.8%
6/103
15.2%
7/46
Metabolism and nutrition disorders
HYPERGLYCAEMIA
4.0%
4/101
5.8%
6/103
13.0%
6/46
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
3.0%
3/101
6.8%
7/103
4.3%
2/46
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
8.9%
9/101
12.6%
13/103
15.2%
7/46
Musculoskeletal and connective tissue disorders
ARTHRALGIA
15.8%
16/101
9.7%
10/103
13.0%
6/46
Musculoskeletal and connective tissue disorders
BACK PAIN
11.9%
12/101
8.7%
9/103
15.2%
7/46
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
14.9%
15/101
17.5%
18/103
2.2%
1/46
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
9.9%
10/101
7.8%
8/103
4.3%
2/46
Musculoskeletal and connective tissue disorders
MYALGIA
13.9%
14/101
1.9%
2/103
13.0%
6/46
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
13.9%
14/101
3.9%
4/103
17.4%
8/46
Nervous system disorders
DIZZINESS
5.0%
5/101
5.8%
6/103
6.5%
3/46
Nervous system disorders
HEADACHE
42.6%
43/101
12.6%
13/103
17.4%
8/46
Psychiatric disorders
DEPRESSION
5.9%
6/101
3.9%
4/103
4.3%
2/46
Psychiatric disorders
INSOMNIA
11.9%
12/101
4.9%
5/103
4.3%
2/46
Respiratory, thoracic and mediastinal disorders
COUGH
10.9%
11/101
8.7%
9/103
8.7%
4/46
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
3.0%
3/101
0.97%
1/103
6.5%
3/46
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
5.9%
6/101
5.8%
6/103
0.00%
0/46
Skin and subcutaneous tissue disorders
ALOPECIA
10.9%
11/101
0.00%
0/103
8.7%
4/46
Skin and subcutaneous tissue disorders
DRY SKIN
19.8%
20/101
0.00%
0/103
6.5%
3/46
Skin and subcutaneous tissue disorders
PRURITUS
29.7%
30/101
0.00%
0/103
4.3%
2/46
Skin and subcutaneous tissue disorders
RASH
29.7%
30/101
3.9%
4/103
19.6%
9/46
Skin and subcutaneous tissue disorders
RASH FOLLICULAR
4.0%
4/101
0.00%
0/103
6.5%
3/46
Vascular disorders
HYPERTENSION
9.9%
10/101
5.8%
6/103
2.2%
1/46

Additional Information

Study Director

Novartis

Phone: 862-778-8300

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 or disclosure of trial results in their entirety.
  • Publication restrictions are in place

Restriction type: OTHER