Trial Outcomes & Findings for Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC (NCT NCT00709761)
NCT ID: NCT00709761
Last Updated: 2019-03-26
Results Overview
OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)
Results posted on
2019-03-26
Participant Flow
Summary of subject disposition table is on the intent-to-treat (ITT) population. The ITT population comprised of all subjects who received at least 1 dose of investigational product. The ITT population, which is the same as the actually treated population, is used for all the analyses of EOS reporting.
A safety cohort was designed into the study to include the first 10 participants enrolled. Enrollment was halted after the enrollment of the fifth participant to allow for the safety review. Enrollment was resumed after the review and protocol amended.
Participant milestones
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
study closed/terminated
|
17
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
Baseline characteristics by cohort
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
n=60 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 12.78 • n=99 Participants
|
|
Age, Customized
<18
|
0 Participants
n=99 Participants
|
|
Age, Customized
18-64 years
|
44 Participants
n=99 Participants
|
|
Age, Customized
65-84 years
|
16 Participants
n=99 Participants
|
|
Age, Customized
85+
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
50 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (Her.)
|
6 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian Her./South East Asian Her.
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian of other Pacific Islander
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian of Alaska Native and White
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product
OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.
Outcome measures
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
n=60 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Overall Tumor Response (OR)
|
53 percentage of participants
|
SECONDARY outcome
Timeframe: Start of treatment to death (up to Week 131)Population: ITT Population
OS was defined as the time from the start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. OS could not be analyzed because only 13 participants had died as of data cut off, and data were not mature (greater than 75% of the participants were censored for the endpoint).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First documented response (CR or PR) to disease progression or death (up to Week 131)Population: ITT Population. Only those participants experiencing a CR or a PR were analyzed.
DOR was defined for the subset of participants who showed a confirmed CR or PR, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.
Outcome measures
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
n=32 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Duration of Response (DOR)
|
48.7 weeks
Interval 31.7 to 57.1
|
SECONDARY outcome
Timeframe: Start of treatment to first documented response (CR or PR) (up to Week 131)Population: ITT Population. Only those participants experiencing a CR or a PR were analyzed.
TTR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first).
Outcome measures
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
n=32 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Time to Response (TTR)
|
7.8 weeks
Interval 7.4 to 8.1
|
SECONDARY outcome
Timeframe: Start of treatment to disease progression or death (up to Week 131)Population: ITT Population
TTP was defined as the interval between the start of treatment until the earliest date of disease progression or death due to breast cancer.
Outcome measures
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
n=60 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Time to Progression (TTP)
|
41.0 weeks
Interval 39.1 to 64.6
|
SECONDARY outcome
Timeframe: Start of treatment to disease progression or death (up to Week 131)Population: ITT Population
PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.
Outcome measures
| Measure |
Lapatinib 1000 mg + Nab-Paclitaxel
n=60 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 mg/ m\^2 intravenously over 30 minutes on Day 1, 8, and 15, in a 4-week cycle, for at least 6 cycles.
|
|---|---|
|
Progression-Free Survival (PFS)
|
39.7 weeks
Interval 34.1 to 63.9
|
Adverse Events
Lapatinib (1000mg) + + Nab-Pacl
Serious events: 21 serious events
Other events: 60 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Lapatinib (1000mg) + + Nab-Pacl
n=60 participants at risk
Participants received Lapatinib 1000 milligram (mg) tablets orally daily hour before or after a meal along with a Nabpaclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m\^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Cardiac disorders
Left ventricular dysfunction
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
3/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Chest pain
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Disease progression
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Sudden death
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Bacteraemia
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Cellulitis
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Nail bed infection
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Urosepsis
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Investigations
Ejection fraction decreased
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
2/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
Other adverse events
| Measure |
Lapatinib (1000mg) + + Nab-Pacl
n=60 participants at risk
Participants received Lapatinib 1000 milligram (mg) tablets orally daily hour before or after a meal along with a Nabpaclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m\^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.0%
21/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
36.7%
22/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Eye disorders
Lacrimation increased
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Constipation
|
23.3%
14/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
88.3%
53/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
10/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
6/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
15.0%
9/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Nausea
|
65.0%
39/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
23/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Asthenia
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Fatigue
|
68.3%
41/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Mucosal inflammation
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Oedema peripheral
|
26.7%
16/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Pain
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
General disorders
Pyrexia
|
18.3%
11/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Sinusitis
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.7%
7/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Investigations
Haemoglobin decreased
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Investigations
Weight decreased
|
18.3%
11/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
15/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
9/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
6/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
7/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
6/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.7%
7/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.7%
7/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.3%
11/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Cognitive disorder
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Dizziness
|
15.0%
9/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
10/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Headache
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Neuropathy peripheral
|
38.3%
23/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Psychiatric disorders
Insomnia
|
18.3%
11/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Renal and urinary disorders
Dysuria
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
15/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
15/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.3%
14/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
24/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
8/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
20.0%
12/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
9/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
48.3%
29/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.7%
4/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Vascular disorders
Hot flush
|
8.3%
5/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Vascular disorders
Hypotension
|
11.7%
7/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
|
Vascular disorders
Lymphoedema
|
10.0%
6/60 • Adverse Events (AEs) and Serious AEs were collected from the first study drug dose administration until 30 days after the last dose and recorded on the eCRF, a total period of approximately 9.5 years.
|
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