Trial Outcomes & Findings for QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer (NCT NCT00626106)
NCT ID: NCT00626106
Last Updated: 2024-09-19
Results Overview
PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
50
|
|
Overall Study
COMPLETED
|
39
|
26
|
|
Overall Study
NOT COMPLETED
|
67
|
24
|
Reasons for withdrawal
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Death
|
64
|
19
|
Baseline Characteristics
QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=106 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=50 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
106 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Postmenopausal Women with Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
|
106 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=106 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=50 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.9 Months
Interval 3.6 to 5.3
|
5.7 Months
Interval 4.4 to 7.4
|
SECONDARY outcome
Timeframe: 30 days after the last dose of study treatment, up to 109 weeksGraded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=106 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=50 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Number of Participants With Adverse Events
|
105 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.Population: PK population, included only subjects who received the specified combination.
Serum AMG 479 Concentrations After IV Administration of 12 mg/kg AMG 479 in combination with Exemestane, and in combination with Fulvestrant (Cmax).
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=70 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Cmax of AMG 479
AMG 479 in combination with Exemestane, Cycle 1 Day 1
|
231 μg/mL
Standard Deviation 61.8
|
—
|
|
Cmax of AMG 479
AMG 479 in combination with Exemestane, Cycle 2 Day 1
|
257 μg/mL
Standard Deviation 66.9
|
—
|
|
Cmax of AMG 479
AMG 479 in combination with Exemestane, Cycle 3 Day 1
|
289 μg/mL
Standard Deviation 52.7
|
—
|
|
Cmax of AMG 479
AMG 479 in combination with Fulvestrant, Cycle 1 Day 1
|
225 μg/mL
Standard Deviation 46.3
|
—
|
|
Cmax of AMG 479
AMG 479 in combination with Fulvestrant, Cycle 2 Day 1
|
267 μg/mL
Standard Deviation 79.3
|
—
|
|
Cmax of AMG 479
AMG 479 in combination with Fulvestrant, Cycle 3 Day 1
|
268 μg/mL
Standard Deviation 66.7
|
—
|
SECONDARY outcome
Timeframe: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.Population: All Randomized Subjects with Baseline Tumor Assessment
Clinical benefit was defined as complete/partial response, or stable disease≥24 weeks per modified RECIST/local review. Objective response rate was defined as complete/partial response per modified RECIST/local review. Per Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease is disease that is not complete, partial or progressive (PD = at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study)
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=63 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=32 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Clinical Benefit and Objective Response Rate
Clinical Benefit Rate
|
22 Participants
|
10 Participants
|
|
Clinical Benefit and Objective Response Rate
Objective Response Rate
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.Population: Subjects with Baseline Measureable Disease and Confirmed Response
Duration of response was defined as time from the date of first confirmed response to the date of first disease progression or death due to any cause in a subset of subjects with confirmed response. Time to response was defined as the interval in days from randomization to the first assessment of objective response (CR or PR). A complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study.
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=5 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=4 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Duration of Response and Time-to-response
Time to Response
|
22.1 Weeks
Standard Deviation 13.1
|
19.5 Weeks
Standard Deviation 13.6
|
|
Duration of Response and Time-to-response
Duration of Response
|
26.5 Weeks
Standard Deviation 10.6
|
31.7 Weeks
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Subject completing study will be contacted by the study staff by telephone or at routine clinic visits approximately every 3 months, up to approximately 3 years and 6 months.Time to progression was defined as the time from date of randomization to the date of first occurrence of disease progression or death due to disease progression Time to treatment failure was defined as the time from date of randomization to the earliest date of disease progression, death, or end of cycle \[last dose date + 1 cycle time: 14 days\] for the last dose of ganitumab or placebo regardless of the reason of discontinuation Overall survival was defined as the time from randomization to death. Progressive disease is at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study.
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=106 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=50 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Time To Progression, Time-to-treatment Failure, Overall Survival
Overall Survival
|
96.6 Weeks
Interval 82.3 to
N/A = Not estimable due to insufficient number of participants with events
|
NA Weeks
Interval 82.6 to
N/A = Not estimable due to insufficient number of participants with events
|
|
Time To Progression, Time-to-treatment Failure, Overall Survival
Time To Progression
|
17.0 Weeks
Interval 15.9 to 23.1
|
24.6 Weeks
Interval 19.0 to 32.0
|
|
Time To Progression, Time-to-treatment Failure, Overall Survival
Time-to-treatment failure
|
15.8 Weeks
Interval 14.0 to 20.0
|
21.6 Weeks
Interval 18.6 to 31.4
|
SECONDARY outcome
Timeframe: From start of study, on Day 1 of cycles 2, 3, and 4 and Day 1 every 3rd cycle thereafter, up to cycle 25 (Cycle = 28 days), approximately 700 days.Population: The European Organization for Research and Treatment of Cancer (EORTC) analysis set consisted of all subjects in the full analysis set who had a baseline and at least 1 postbaseline non-missing measurable score of the EORTC QLQ-C30 questionnaire for descriptive comparisons between treatment groups.
Based on the European Organization Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C-30) v3, a 30-item questionnaire comprised of 5 functional scales, 3 symptom scales, and 6 single item scales, all with scores ranging from 1=not at all to 4=very much, along with the Health-Related Quality of Life scale with scores ranging from 1=very poor to 7=excellent; and 2 questions from the Dermatology Life Quality Index (DLQI; scores ranged from 1=not at all to 4=very much). Summing of all these questions and standardizing yielded a total score ranging from 0-100; higher total scores = better quality of life. AUC of the change from baseline of the mean total score over time were calculated using the linear trapezoidal rule. The time-adjusted AUC was calculated by dividing the AUC by the time interval between baseline and the last scheduled assessment, the difference was analyzed using analysis of covariance with baseline score and stratification factors as covariates.
Outcome measures
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=95 Participants
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=45 Participants
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Global Health Status Time-Adjusted AUC
|
1.56 scores*day
Interval 0.55 to 1.95
|
1.59 scores*day
Interval 1.18 to 1.95
|
Adverse Events
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
Serious events: 27 serious events
Other events: 105 other events
Deaths: 64 deaths
Arm B: Placebo IV Q2W + Endocrine Therapy
Serious events: 9 serious events
Other events: 47 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=106 participants at risk
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=49 participants at risk
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Stomatitis
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Subileus
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Vomiting
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
General Physical Health Deterioration
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Asthenia
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Chest Pain
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Malaise
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Appendicitis
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Campylobacter Intestinal Infection
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Pneumonia
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Sepsis
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Migraine
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Dizziness
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Headache
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Horner's Syndrome
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Sciatica
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Renal and urinary disorders
Renal Failure
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Renal and urinary disorders
Renal Impairment
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Cardiac disorders
Myocardial Infarction
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Immune system disorders
Drug Hypersensitivity
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
Other adverse events
| Measure |
Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy
n=106 participants at risk
AMG 479: AMG 479 administered with exemestane or fulvestrant
|
Arm B: Placebo IV Q2W + Endocrine Therapy
n=49 participants at risk
Placebo: Placebo administered with either exemestane or fulvestrant
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
39.6%
42/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
38.8%
19/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
31.1%
33/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
28.6%
14/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
23/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
20.4%
10/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Constipation
|
15.1%
16/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
18.4%
9/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
12.2%
6/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
14.3%
7/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Fatigue
|
39.6%
42/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
24.5%
12/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Asthenia
|
22.6%
24/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
36.7%
18/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Pyrexia
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Mucosal Inflammation
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Chills
|
9.4%
10/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Oedema Peripheral
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Chest Pain
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Pain
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Infusion Related Reaction
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
General disorders
Injection Site Pain
|
2.8%
3/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.7%
23/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
22.4%
11/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.9%
20/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
24.5%
12/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
16.0%
17/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
14.3%
7/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
14.2%
15/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
14.3%
7/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.5%
9/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
14.3%
7/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.4%
10/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
12.2%
6/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Headache
|
23.6%
25/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
26.5%
13/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Dizziness
|
10.4%
11/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Dysgeusia
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Paraesthesia
|
4.7%
5/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Sciatica
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Tremor
|
4.7%
5/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Migraine
|
1.9%
2/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Nervous system disorders
Somnolence
|
0.94%
1/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.9%
20/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
14.3%
7/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
18.4%
9/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
12.2%
6/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Urinary Tract Infection
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Infections and infestations
Sinusitis
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.2%
15/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
10/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
3.8%
4/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
15.1%
16/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
14.3%
7/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Vascular disorders
Hot Flush
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
24.5%
12/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Vascular disorders
Hypertension
|
5.7%
6/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Psychiatric disorders
Insomnia
|
11.3%
12/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
16.3%
8/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Psychiatric disorders
Anxiety
|
10.4%
11/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
12.2%
6/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Psychiatric disorders
Depression
|
6.6%
7/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.0%
18/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
9/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
8.2%
4/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.4%
11/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
2.0%
1/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Investigations
Weight Decreased
|
8.5%
9/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Injury, poisoning and procedural complications
Contusion
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
0.00%
0/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
3/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
6.1%
3/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
3/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
10.2%
5/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
|
Immune system disorders
Hypersensitivity
|
7.5%
8/106 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
4.1%
2/49 • 30 days after the last dose of study treatment, up to 109 weeks
Mortality was measured for all subjects, adverse events were measured for the safety population (all subjects who received at least 1 dose of treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place