Trial Outcomes & Findings for ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer. (NCT NCT02681523)
NCT ID: NCT02681523
Last Updated: 2024-09-19
Results Overview
Estimated Kaplan-Meier Progression free survival (PFS) to be defined as time from study entry to first evidence of disease progression or death due to any cause, as assessed by RECIST v1.0.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Fixed timepoints - 3, 6 and 9 months
Results posted on
2024-09-19
Participant Flow
This was a pilot of proof study recruiting 8 breast cancer patients over a 2 year period from the Charing Cross Hospital, London. The last patient completed in July 2018.
Of the 58 patients screened, during the period between February 2016 and July 2018, 13 patients were consented to the study; and upon screening, 8 were recruited to receive study treatment, eribulin1.23mg/m2 on day 1 and day 8 of 21 day cycles, alternated with an aromatase inhibitor (AI), orally once daily for 9 weeks.
Participant milestones
| Measure |
Single Arm Study
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This was then followed by 9 weeks of an Aromatase Inhibitor (AI) treatment (either letrozole, exemestane or anastrozole), followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients remained on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever was sooner.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Arm Study
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This was then followed by 9 weeks of an Aromatase Inhibitor (AI) treatment (either letrozole, exemestane or anastrozole), followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients remained on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever was sooner.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Patient Non-compliance
|
1
|
Baseline Characteristics
ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer.
Baseline characteristics by cohort
| Measure |
Single Arm Study
n=8 Participants
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Middle Eastern
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Turkish
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performamce Status 0
|
4 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performamce Status 1
|
4 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performamce Status 2
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performamce Status 3
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performamce Status 4
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Performamce Status 5
|
0 Participants
n=5 Participants
|
|
Smoking Status
Never
|
3 Participants
n=5 Participants
|
|
Smoking Status
Former
|
3 Participants
n=5 Participants
|
|
Smoking Status
Current
|
1 Participants
n=5 Participants
|
|
Smoking Status
No Information
|
1 Participants
n=5 Participants
|
|
Tumour Type
Invasive Ducal Carcinoma
|
8 Participants
n=5 Participants
|
|
Tumour Type
Other Tumour type
|
0 Participants
n=5 Participants
|
|
Oestrogen Receptor (ER) Status Assessment Method
Allred
|
3 Participants
n=5 Participants
|
|
Oestrogen Receptor (ER) Status Assessment Method
Other
|
5 Participants
n=5 Participants
|
|
Progesterone Receptors (PgR) Status
Positive
|
7 Participants
n=5 Participants
|
|
Progesterone Receptors (PgR) Status
Negative
|
0 Participants
n=5 Participants
|
|
Progesterone Receptors (PgR) Status
Unknown
|
1 Participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
Zero
|
5 Participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
1+
|
1 Participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
2+
|
0 Participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
3+
|
0 Participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
Not measured
|
2 Participants
n=5 Participants
|
|
Primary Tumour Stage
Stage I
|
1 Participants
n=5 Participants
|
|
Primary Tumour Stage
Stage IIA
|
1 Participants
n=5 Participants
|
|
Primary Tumour Stage
Stage IIIA
|
1 Participants
n=5 Participants
|
|
Primary Tumour Stage
Stage IIIC
|
1 Participants
n=5 Participants
|
|
Primary Tumour Stage
No information
|
4 Participants
n=5 Participants
|
|
Primary Tumour Grade
Grade 1
|
1 Participants
n=5 Participants
|
|
Primary Tumour Grade
Grade 2
|
5 Participants
n=5 Participants
|
|
Primary Tumour Grade
Grade 3
|
2 Participants
n=5 Participants
|
|
Prior Chemotherapy
Yes
|
8 Participants
n=5 Participants
|
|
Prior Chemotherapy
No
|
0 Participants
n=5 Participants
|
|
Prior Radiotherapy
Yes
|
8 Participants
n=5 Participants
|
|
Prior Radiotherapy
No
|
0 Participants
n=5 Participants
|
|
Prior Surgery
Yes
|
8 Participants
n=5 Participants
|
|
Prior Surgery
No
|
0 Participants
n=5 Participants
|
|
Prior Endocrine Therapy
Tamoxifen
|
8 participants
n=5 Participants
|
|
Prior Endocrine Therapy
Exemestane
|
5 participants
n=5 Participants
|
|
Prior Endocrine Therapy
Letrozole
|
3 participants
n=5 Participants
|
|
Prior Endocrine Therapy
Anastrozole
|
5 participants
n=5 Participants
|
|
Body Mass Index
|
26.5 kg/m^2
n=5 Participants
|
|
Primary Tumour Size
|
28 millimeteres (mm)
n=5 Participants
|
PRIMARY outcome
Timeframe: Fixed timepoints - 3, 6 and 9 monthsPopulation: PFS was measured at fixed time points of 3, 6 and 9 months, as estimated by the Kaplan-Meier curve. The median PFS at the end of the study was 235 days. PFS could not be calculated at 3 months, as no patient experienced disease progression at follow-up.
Estimated Kaplan-Meier Progression free survival (PFS) to be defined as time from study entry to first evidence of disease progression or death due to any cause, as assessed by RECIST v1.0.
Outcome measures
| Measure |
Single Arm Study
n=8 Participants
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
|
|---|---|
|
Estimated Kaplan-Meier Progression Free Survival as Assessed by RECIST v1.1
3 months
|
NA Days
PFS could not be calculated at 3 months, as no patient experienced disease progression at follow-up.
|
|
Estimated Kaplan-Meier Progression Free Survival as Assessed by RECIST v1.1
6 months
|
202 Days
A valid confidence interval cannot be accurately calculated for the PFS at 6 months, as only one patient experienced disease progression at follow-up and the given sample size (n=8) is small.
|
|
Estimated Kaplan-Meier Progression Free Survival as Assessed by RECIST v1.1
9 months
|
235 Days
A valid confidence interval cannot be accurately calculated for the PFS at 9 months, as only three patients experienced disease progression at follow-up and the given sample size (n=8) is small.
|
SECONDARY outcome
Timeframe: To be assessed at 3, 6 and 9 months.Population: Only 6 patients had at least one tumour assessment during the study period.
Clinical benefit rate (CBR), defined as the proportion of patients whose best overall response according to Response Evaluation Criteria in Solid Tumours (RECIST), v1.0 is either a complete response, partial response or stable disease for a least 6 months.
Outcome measures
| Measure |
Single Arm Study
n=6 Participants
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
|
|---|---|
|
Clinical Benefit Rate as Assessed by RECIST v1.1
Complete Response
|
0 Participants
|
|
Clinical Benefit Rate as Assessed by RECIST v1.1
Partial response
|
3 Participants
|
|
Clinical Benefit Rate as Assessed by RECIST v1.1
Stable Disease
|
3 Participants
|
SECONDARY outcome
Timeframe: Collected form consent to follow-upPopulation: AEs and SAEs were collected for all 8 subjects who received at least one dose of study treatment
Safety and Tolerability were assessed by adverse events (AEs) and serious adverse events (SAEs) according the Common Terminology Criteria for Adverse Event (NCI-CTCAE) v4.03.
Outcome measures
| Measure |
Single Arm Study
n=129 Events
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
|
|---|---|
|
Safety and Tolerability
Mild
|
71 Events
|
|
Safety and Tolerability
Moderate
|
39 Events
|
|
Safety and Tolerability
Severe
|
17 Events
|
|
Safety and Tolerability
Life Threatening or disabling
|
2 Events
|
|
Safety and Tolerability
Death
|
0 Events
|
Adverse Events
Single Arm Study
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Study
n=8 participants at risk
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
|
|---|---|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Infections and infestations
Neutopenic Sepsis
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Mucositis
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress syndrome
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Ischaemia cerebrovascular
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
Other adverse events
| Measure |
Single Arm Study
n=8 participants at risk
3 x 3 weekly cycles at the recommended dose of eribulin as the ready to use solution, 1.23 mg/m2, administered intravenously over 2-5 minutes on days 1 and 8 of every 21 day cycle. This will then be followed by 9 weeks of AI treatment, to be followed again by 3 x 3 weekly cycles of eribulin and 9 weeks AI treatment. Patients will remain on treatment for up to 9 months, or until disease progression or unacceptable toxicities, whichever is sooner.
|
|---|---|
|
Vascular disorders
Flushing
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 6 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Mucosal inflammation gg
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Pain
|
37.5%
3/8 • Number of events 4 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Peripheral swelling
|
37.5%
3/8 • Number of events 3 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Aspartate aminotransferase
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Blood alkaline phosphatase
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Blood cholesterol increased
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Grip strength decreased
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
Weight decreased
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 3 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoe
|
50.0%
4/8 • Number of events 6 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Ageusia
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Diziness
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
50.0%
4/8 • Number of events 4 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Sciatica
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Nervous system disorders
Cognitive disorder
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
37.5%
3/8 • Number of events 3 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
4/8 • Number of events 4 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Heartburn/burping
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Melaena
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 4 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Teeth and gum darkening
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Teeth and gum thinning
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Hepatobiliary disorders
Hepatic pain
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Hepatobiliary disorders
Hepatomegaly
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.0%
6/8 • Number of events 6 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • Number of events 3 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Infections and infestations
Ear infection
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Infections and infestations
Neutropenic sepsis
|
25.0%
2/8 • Number of events 2 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Infections and infestations
Oral herpes
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
|
Infections and infestations
Vaginal infection
|
12.5%
1/8 • Number of events 1 • Collected from consent to follow-up for all subjects who receive at least one dose of study treatment, 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place