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Trial Outcomes & Findings for A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation (NCT NCT01028222)

NCT ID: NCT01028222

Last Updated: 2015-12-30

Results Overview

ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

End of study (up to 39 months)

Results posted on

2015-12-30

Participant Flow

Participant milestones

Participant milestones
Measure
Nilotinib
400 mg twice daily
DTIC
850 mg/m2 IV every 3 weeks
Overall Study
STARTED
42
13
Overall Study
Cross Over From DTIC to Nilotinib
0
10
Overall Study
COMPLETED
4
0
Overall Study
NOT COMPLETED
38
13

Reasons for withdrawal

Reasons for withdrawal
Measure
Nilotinib
400 mg twice daily
DTIC
850 mg/m2 IV every 3 weeks
Overall Study
Protocol deviation
1
0
Overall Study
Disease progression
33
9
Overall Study
Administrative problems
1
1
Overall Study
Lost to Follow-up
0
1
Overall Study
Withdrawal by Subject
1
0
Overall Study
Crossover to nilotinib w/out progression
0
2
Overall Study
Adverse Event
2
0

Baseline Characteristics

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Total
n=55 Participants
Total of all reporting groups
Age, Continuous
64.7 Years
STANDARD_DEVIATION 12.39 • n=93 Participants
68.8 Years
STANDARD_DEVIATION 12.99 • n=4 Participants
66.8 Years
STANDARD_DEVIATION 12.69 • n=27 Participants
Sex: Female, Male
Female
23 Participants
n=93 Participants
8 Participants
n=4 Participants
31 Participants
n=27 Participants
Sex: Female, Male
Male
19 Participants
n=93 Participants
5 Participants
n=4 Participants
24 Participants
n=27 Participants

PRIMARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Overall Response Rate (ORR)
11 Participants
3 Participants

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Durable Overall Response Rate (DORR)
11 Participants
3 Participants

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a \>=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Progression Free Survival (PFS)
4.2 Months
Interval 2.1 to 5.8
4.2 Months
Interval 0.8 to 8.0

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

OS was defined as the time from the date of the start of treatment to the date of death due to any cause.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Overall Survival (OS)
18.0 Months
Interval 10.9 to 20.3
22.8 Months
Interval 4.9 to
The 95% Confidence upper interval could not be calculated because there were too few events.

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Time to Objective Response (TOR)
NA months
The TOR median could not be reached because there were too few events.
NA months
The TOR median could not be reached because there were too few events.

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
Disease Control Rate (DCR)
20 Participants
7 Participants

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a \>=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
PFS Rate
34.6 Percentage of participants
23.1 Percentage of participants

SECONDARY outcome

Timeframe: End of study (up to 39 months)

Population: Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

OS was defined as the time from the date of the start of treatment to the date of death due to any cause.

Outcome measures

Outcome measures
Measure
Nilotinib
n=42 Participants
400 mg twice daily
DTIC
n=13 Participants
850 mg/m2 IV every 3 weeks
OS Rate
63.6 Percentage of participants
66.7 Percentage of participants

Adverse Events

Nilotinib

Serious events: 12 serious events
Other events: 40 other events
Deaths: 0 deaths

DTIC

Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths

Crossover Nilotinib Treatment

Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Nilotinib
n=42 participants at risk
400 mg twice daily
DTIC
n=13 participants at risk
850 mg/m2 IV every 3 weeks
Crossover Nilotinib Treatment
n=10 participants at risk
Crossover nilotinib treatment
Cardiac disorders
Angina pectoris
2.4%
1/42
0.00%
0/13
0.00%
0/10
Cardiac disorders
Arrhythmia
0.00%
0/42
0.00%
0/13
10.0%
1/10
Cardiac disorders
Myocardial infarction
0.00%
0/42
0.00%
0/13
10.0%
1/10
Eye disorders
Retinal detachment
0.00%
0/42
0.00%
0/13
10.0%
1/10
Eye disorders
Visual impairment
2.4%
1/42
0.00%
0/13
0.00%
0/10
Gastrointestinal disorders
Abdominal pain
4.8%
2/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Abdominal pain upper
2.4%
1/42
0.00%
0/13
0.00%
0/10
Gastrointestinal disorders
Ascites
0.00%
0/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Nausea
7.1%
3/42
0.00%
0/13
0.00%
0/10
Gastrointestinal disorders
Vomiting
7.1%
3/42
0.00%
0/13
0.00%
0/10
General disorders
Asthenia
2.4%
1/42
0.00%
0/13
0.00%
0/10
General disorders
Fatigue
2.4%
1/42
0.00%
0/13
0.00%
0/10
General disorders
General physical health deterioration
0.00%
0/42
0.00%
0/13
10.0%
1/10
General disorders
Malaise
2.4%
1/42
0.00%
0/13
0.00%
0/10
General disorders
Oedema peripheral
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Herpes zoster cutaneous disseminated
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Infection
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Lower respiratory tract infection
2.4%
1/42
0.00%
0/13
0.00%
0/10
Infections and infestations
Pneumonia
0.00%
0/42
7.7%
1/13
0.00%
0/10
Injury, poisoning and procedural complications
Ankle fracture
2.4%
1/42
0.00%
0/13
0.00%
0/10
Injury, poisoning and procedural complications
Joint dislocation
2.4%
1/42
0.00%
0/13
0.00%
0/10
Investigations
Amylase increased
2.4%
1/42
0.00%
0/13
0.00%
0/10
Investigations
Blood creatinine increased
2.4%
1/42
0.00%
0/13
0.00%
0/10
Investigations
Lipase increased
4.8%
2/42
0.00%
0/13
0.00%
0/10
Metabolism and nutrition disorders
Dehydration
2.4%
1/42
0.00%
0/13
0.00%
0/10
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/42
0.00%
0/13
10.0%
1/10
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/42
0.00%
0/13
10.0%
1/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
2.4%
1/42
0.00%
0/13
10.0%
1/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/42
0.00%
0/13
10.0%
1/10
Nervous system disorders
Dizziness
2.4%
1/42
0.00%
0/13
0.00%
0/10
Nervous system disorders
Epilepsy
0.00%
0/42
0.00%
0/13
10.0%
1/10
Renal and urinary disorders
Haematuria
2.4%
1/42
0.00%
0/13
0.00%
0/10
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.4%
1/42
0.00%
0/13
0.00%
0/10

Other adverse events

Other adverse events
Measure
Nilotinib
n=42 participants at risk
400 mg twice daily
DTIC
n=13 participants at risk
850 mg/m2 IV every 3 weeks
Crossover Nilotinib Treatment
n=10 participants at risk
Crossover nilotinib treatment
Blood and lymphatic system disorders
Anaemia
11.9%
5/42
0.00%
0/13
0.00%
0/10
Blood and lymphatic system disorders
Leukopenia
7.1%
3/42
0.00%
0/13
0.00%
0/10
Blood and lymphatic system disorders
Lymphopenia
7.1%
3/42
0.00%
0/13
10.0%
1/10
Blood and lymphatic system disorders
Neutropenia
4.8%
2/42
7.7%
1/13
0.00%
0/10
Blood and lymphatic system disorders
Thrombocytopenia
2.4%
1/42
7.7%
1/13
0.00%
0/10
Cardiac disorders
Sinus bradycardia
0.00%
0/42
0.00%
0/13
10.0%
1/10
Ear and labyrinth disorders
Otorrhoea
0.00%
0/42
7.7%
1/13
0.00%
0/10
Ear and labyrinth disorders
Vertigo
0.00%
0/42
0.00%
0/13
10.0%
1/10
Eye disorders
Eye pruritus
2.4%
1/42
0.00%
0/13
10.0%
1/10
Eye disorders
Lacrimation increased
0.00%
0/42
0.00%
0/13
10.0%
1/10
Eye disorders
Vision blurred
2.4%
1/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Abdominal distension
7.1%
3/42
0.00%
0/13
0.00%
0/10
Gastrointestinal disorders
Abdominal pain upper
9.5%
4/42
0.00%
0/13
0.00%
0/10
Gastrointestinal disorders
Constipation
21.4%
9/42
7.7%
1/13
0.00%
0/10
Gastrointestinal disorders
Diarrhoea
16.7%
7/42
7.7%
1/13
30.0%
3/10
Gastrointestinal disorders
Dyspepsia
7.1%
3/42
7.7%
1/13
0.00%
0/10
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Nausea
42.9%
18/42
38.5%
5/13
20.0%
2/10
Gastrointestinal disorders
Odynophagia
2.4%
1/42
7.7%
1/13
10.0%
1/10
Gastrointestinal disorders
Oral discomfort
0.00%
0/42
7.7%
1/13
0.00%
0/10
Gastrointestinal disorders
Oral pain
0.00%
0/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Tongue ulceration
0.00%
0/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Toothache
0.00%
0/42
0.00%
0/13
10.0%
1/10
Gastrointestinal disorders
Vomiting
26.2%
11/42
7.7%
1/13
10.0%
1/10
General disorders
Asthenia
4.8%
2/42
7.7%
1/13
30.0%
3/10
General disorders
Chills
7.1%
3/42
0.00%
0/13
0.00%
0/10
General disorders
Fatigue
31.0%
13/42
38.5%
5/13
40.0%
4/10
General disorders
Feeling cold
0.00%
0/42
7.7%
1/13
0.00%
0/10
General disorders
General physical health deterioration
0.00%
0/42
0.00%
0/13
10.0%
1/10
General disorders
Oedema peripheral
7.1%
3/42
7.7%
1/13
20.0%
2/10
General disorders
Pain
0.00%
0/42
0.00%
0/13
10.0%
1/10
General disorders
Pyrexia
7.1%
3/42
23.1%
3/13
20.0%
2/10
General disorders
Suprapubic pain
2.4%
1/42
0.00%
0/13
10.0%
1/10
General disorders
Temperature intolerance
0.00%
0/42
0.00%
0/13
10.0%
1/10
General disorders
Ulcer haemorrhage
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Conjunctivitis
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Ear infection
0.00%
0/42
7.7%
1/13
0.00%
0/10
Infections and infestations
Erysipelas
0.00%
0/42
7.7%
1/13
0.00%
0/10
Infections and infestations
Gastrointestinal infection
0.00%
0/42
7.7%
1/13
10.0%
1/10
Infections and infestations
Gingivitis
0.00%
0/42
7.7%
1/13
0.00%
0/10
Infections and infestations
Herpes zoster
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Influenza
4.8%
2/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Nasopharyngitis
7.1%
3/42
15.4%
2/13
20.0%
2/10
Infections and infestations
Oral fungal infection
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Oral herpes
2.4%
1/42
7.7%
1/13
0.00%
0/10
Infections and infestations
Pneumonia
2.4%
1/42
7.7%
1/13
10.0%
1/10
Infections and infestations
Sinusitis
2.4%
1/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Staphylococcal infection
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Tooth infection
0.00%
0/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Upper respiratory tract infection
2.4%
1/42
0.00%
0/13
10.0%
1/10
Infections and infestations
Urinary tract infection
7.1%
3/42
0.00%
0/13
0.00%
0/10
Injury, poisoning and procedural complications
Fall
0.00%
0/42
7.7%
1/13
0.00%
0/10
Injury, poisoning and procedural complications
Wound
0.00%
0/42
7.7%
1/13
0.00%
0/10
Investigations
Alanine aminotransferase increased
23.8%
10/42
7.7%
1/13
10.0%
1/10
Investigations
Amylase increased
19.0%
8/42
0.00%
0/13
0.00%
0/10
Investigations
Aspartate aminotransferase increased
19.0%
8/42
7.7%
1/13
0.00%
0/10
Investigations
Bilirubin conjugated increased
26.2%
11/42
0.00%
0/13
10.0%
1/10
Investigations
Blood alkaline phosphatase increased
11.9%
5/42
0.00%
0/13
0.00%
0/10
Investigations
Blood bilirubin increased
45.2%
19/42
7.7%
1/13
30.0%
3/10
Investigations
Blood bilirubin unconjugated increased
21.4%
9/42
0.00%
0/13
10.0%
1/10
Investigations
Blood cholesterol increased
0.00%
0/42
7.7%
1/13
0.00%
0/10
Investigations
Blood creatinine increased
4.8%
2/42
0.00%
0/13
20.0%
2/10
Investigations
Blood lactate dehydrogenase increased
9.5%
4/42
0.00%
0/13
10.0%
1/10
Investigations
Blood phosphorus decreased
0.00%
0/42
0.00%
0/13
10.0%
1/10
Investigations
Blood pressure decreased
9.5%
4/42
0.00%
0/13
0.00%
0/10
Investigations
Blood pressure increased
0.00%
0/42
7.7%
1/13
10.0%
1/10
Investigations
Gamma-glutamyltransferase increased
26.2%
11/42
7.7%
1/13
10.0%
1/10
Investigations
Haemoglobin decreased
4.8%
2/42
0.00%
0/13
20.0%
2/10
Investigations
Lipase increased
19.0%
8/42
7.7%
1/13
20.0%
2/10
Investigations
Low density lipoprotein increased
0.00%
0/42
0.00%
0/13
10.0%
1/10
Investigations
Neutrophil count decreased
0.00%
0/42
7.7%
1/13
0.00%
0/10
Investigations
Platelet count decreased
0.00%
0/42
7.7%
1/13
0.00%
0/10
Investigations
Total bile acids increased
2.4%
1/42
0.00%
0/13
10.0%
1/10
Metabolism and nutrition disorders
Decreased appetite
31.0%
13/42
15.4%
2/13
30.0%
3/10
Metabolism and nutrition disorders
Dehydration
0.00%
0/42
0.00%
0/13
10.0%
1/10
Metabolism and nutrition disorders
Hypercholesterolaemia
9.5%
4/42
7.7%
1/13
10.0%
1/10
Metabolism and nutrition disorders
Hyperglycaemia
21.4%
9/42
7.7%
1/13
30.0%
3/10
Metabolism and nutrition disorders
Hyperkalaemia
7.1%
3/42
0.00%
0/13
0.00%
0/10
Metabolism and nutrition disorders
Hypertriglyceridaemia
4.8%
2/42
7.7%
1/13
20.0%
2/10
Metabolism and nutrition disorders
Hyperuricaemia
7.1%
3/42
0.00%
0/13
0.00%
0/10
Metabolism and nutrition disorders
Hypocalcaemia
11.9%
5/42
0.00%
0/13
10.0%
1/10
Metabolism and nutrition disorders
Hypokalaemia
14.3%
6/42
0.00%
0/13
0.00%
0/10
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/42
0.00%
0/13
10.0%
1/10
Musculoskeletal and connective tissue disorders
Arthralgia
9.5%
4/42
0.00%
0/13
10.0%
1/10
Musculoskeletal and connective tissue disorders
Back pain
4.8%
2/42
0.00%
0/13
10.0%
1/10
Musculoskeletal and connective tissue disorders
Bone pain
2.4%
1/42
0.00%
0/13
10.0%
1/10
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/42
15.4%
2/13
0.00%
0/10
Musculoskeletal and connective tissue disorders
Muscular weakness
2.4%
1/42
0.00%
0/13
10.0%
1/10
Musculoskeletal and connective tissue disorders
Myalgia
4.8%
2/42
7.7%
1/13
0.00%
0/10
Musculoskeletal and connective tissue disorders
Pain in extremity
11.9%
5/42
15.4%
2/13
20.0%
2/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
0.00%
0/42
7.7%
1/13
0.00%
0/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/42
7.7%
1/13
10.0%
1/10
Nervous system disorders
Amnesia
2.4%
1/42
0.00%
0/13
10.0%
1/10
Nervous system disorders
Diabetic neuropathy
0.00%
0/42
0.00%
0/13
10.0%
1/10
Nervous system disorders
Dizziness
7.1%
3/42
15.4%
2/13
20.0%
2/10
Nervous system disorders
Epilepsy
0.00%
0/42
0.00%
0/13
10.0%
1/10
Nervous system disorders
Headache
14.3%
6/42
38.5%
5/13
30.0%
3/10
Nervous system disorders
Hypoaesthesia
0.00%
0/42
0.00%
0/13
10.0%
1/10
Nervous system disorders
Monoplegia
0.00%
0/42
7.7%
1/13
0.00%
0/10
Nervous system disorders
Paraesthesia
0.00%
0/42
7.7%
1/13
0.00%
0/10
Nervous system disorders
Speech disorder
0.00%
0/42
0.00%
0/13
10.0%
1/10
Psychiatric disorders
Anxiety
4.8%
2/42
7.7%
1/13
0.00%
0/10
Psychiatric disorders
Confusional state
0.00%
0/42
0.00%
0/13
10.0%
1/10
Psychiatric disorders
Depression
0.00%
0/42
7.7%
1/13
0.00%
0/10
Psychiatric disorders
Insomnia
11.9%
5/42
7.7%
1/13
0.00%
0/10
Reproductive system and breast disorders
Vaginal haemorrhage
2.4%
1/42
7.7%
1/13
10.0%
1/10
Respiratory, thoracic and mediastinal disorders
Cough
21.4%
9/42
15.4%
2/13
30.0%
3/10
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.9%
5/42
7.7%
1/13
10.0%
1/10
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/42
0.00%
0/13
10.0%
1/10
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/42
0.00%
0/13
10.0%
1/10
Respiratory, thoracic and mediastinal disorders
Nasal congestion
2.4%
1/42
7.7%
1/13
0.00%
0/10
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/42
7.7%
1/13
0.00%
0/10
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/42
7.7%
1/13
10.0%
1/10
Skin and subcutaneous tissue disorders
Actinic keratosis
0.00%
0/42
0.00%
0/13
10.0%
1/10
Skin and subcutaneous tissue disorders
Alopecia
11.9%
5/42
7.7%
1/13
20.0%
2/10
Skin and subcutaneous tissue disorders
Dry skin
2.4%
1/42
7.7%
1/13
0.00%
0/10
Skin and subcutaneous tissue disorders
Erythema
2.4%
1/42
0.00%
0/13
10.0%
1/10
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/42
7.7%
1/13
0.00%
0/10
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/42
7.7%
1/13
0.00%
0/10
Skin and subcutaneous tissue disorders
Pruritus
7.1%
3/42
7.7%
1/13
10.0%
1/10
Skin and subcutaneous tissue disorders
Rash
47.6%
20/42
15.4%
2/13
30.0%
3/10
Skin and subcutaneous tissue disorders
Skin burning sensation
0.00%
0/42
7.7%
1/13
0.00%
0/10
Skin and subcutaneous tissue disorders
Skin exfoliation
2.4%
1/42
0.00%
0/13
10.0%
1/10
Skin and subcutaneous tissue disorders
Skin hypopigmentation
0.00%
0/42
7.7%
1/13
0.00%
0/10
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/42
0.00%
0/13
20.0%
2/10
Vascular disorders
Hypertension
7.1%
3/42
0.00%
0/13
20.0%
2/10
Vascular disorders
Lymphoedema
2.4%
1/42
7.7%
1/13
0.00%
0/10
Vascular disorders
Vein disorder
0.00%
0/42
7.7%
1/13
10.0%
1/10

Additional Information

Novartis

Study Director

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