Trial Outcomes & Findings for MK-3475 Immunotherapy in Endometrial Carcinoma (NCT NCT02630823)
NCT ID: NCT02630823
Last Updated: 2025-01-03
Results Overview
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Through 90 days following last dose of MK-3475 (approximately 56 weeks)
Results posted on
2025-01-03
Participant Flow
Participant milestones
| Measure |
Arm 1: MK-3475
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: MK-3475
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Did not undergo cytoreductive surgery due to pre-operative disease progression
|
1
|
Baseline Characteristics
MK-3475 Immunotherapy in Endometrial Carcinoma
Baseline characteristics by cohort
| Measure |
Arm 1: MK-3475
n=10 Participants
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 90 days following last dose of MK-3475 (approximately 56 weeks)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting
Outcome measures
| Measure |
Arm 1: MK-3475
n=10 Participants
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Abdominal pain
|
10 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Nausea
|
9 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Constipation
|
8 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Cough
|
8 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Dyspnea
|
8 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Peripheral neuropathy
|
8 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Alopecia
|
7 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Fatigue
|
7 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Anemia
|
6 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Blurred vision
|
6 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Depression
|
6 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Bloating
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Bruising
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Headache
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hyperglycemia
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Vaginal hemorrhage
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Vomiting
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Leukocytosis
|
5 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Increased ALT
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Anorexia
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Back pain
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hot flashes
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hypoalbuminemia
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Myalgia
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Pain in extremity
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Rash acneiform
|
4 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Increased alkaline phosphatase
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Chest pain
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Dizziness
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hypocalcemia
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hyponatremia
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Neutropenia
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Palpitations
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Rash maculo-papular
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Urinary incontinence
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Limb edema
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Infusion related reaction
|
3 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Abdominal distension
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Anxiety
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Increased AST
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Chills
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Dysmenorrhea
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hearing impaired
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hematuria
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hyperkalemia
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hypokalemia
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Hypothyroid
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Malaise
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Menorrhagia
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Mucositis
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Pain
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Decreased platelets
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Pruritus
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Respiratory, thoracic and mediastinal disorders
|
2 Participants
|
|
Safety as Measured by Any Grade Treatment Related Adverse Events Experienced by ≥ 2 Patients
Urinary urgency
|
2 Participants
|
PRIMARY outcome
Timeframe: Through 90 days following last dose of MK-3475 (approximately 56 weeks)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting
Outcome measures
| Measure |
Arm 1: MK-3475
n=10 Participants
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Anemia
|
4 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Neutropenia
|
3 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Hyperglycemia
|
2 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Decreased white blood cells
|
2 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Menorrhagia
|
1 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Heart failure
|
1 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Hypophosphatemia
|
1 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Pulmonary edema
|
1 Participants
|
|
Safety as Measured by Any Grade 3 or Higher Treatment Related Adverse Events
Bone infection
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years following completion of therapy (median follow-up of 35 months (full range 11.3-46 months)* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Arm 1: MK-3475
n=10 Participants
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Progression-free Survival (PFS)
|
201.3 weeks
Standard Deviation 160.4
|
Adverse Events
Arm 1: MK-3475
Serious events: 1 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm 1: MK-3475
n=10 participants at risk
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Cardiac disorders
Congestive heart failure
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pretension
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
Other adverse events
| Measure |
Arm 1: MK-3475
n=10 participants at risk
* Patients will undergo endometrial biopsy followed by 2 doses of MK-3475 3 weeks apart. 3-4 weeks after the second dose of MK-3475, the standard of care surgical resection will take place, followed by standard of care adjuvant therapy. Tissue and blood will be collected at the time of surgical resection for immune analysis. For patients whose pathology confirms high-risk features and advanced stage, MK-3475 will be given every 3 weeks starting 4 -6 weeks after completion of adjuvant therapy for a maximum of 4 doses post-surgery.
* MK-3475 will be given intravenously at a dose of 200 mg over the course of 30 minutes.
* The standard of care chemotherapy will consist of 6 cycles of paclitaxel and carboplatin AUC 5 every 3 weeks for 6 cycles.
* The decision to administer radiation therapy will be per the treating physician. If the patient does not receive radiation therapy, then the patient will start MK-3475 every 3 weeks x 4 doses after the completion of chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
6/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Cardiac disorders
Chest pain - cardiac
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Cardiac disorders
Palpitations
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Ear and labyrinth disorders
Hearing impaired
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Eye disorders
Changes in vision - near sighted
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Eye disorders
Blurred vision
|
60.0%
6/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Dysgeusia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
90.0%
9/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Bloating
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Constipation
|
80.0%
8/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Nausea
|
90.0%
9/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Night sweats
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Chills
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Edema face
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Edema limbs
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Edema trunk
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Fatigue
|
70.0%
7/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Fever
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Infusion related reaction
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Malaise
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
General disorders
Pain
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Infections and infestations
Bone infection
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Injury, poisoning and procedural complications
Bruising
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Injury, poisoning and procedural complications
Wound complication
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Ejection fraction decreased
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Neutrophil count decreased
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
Platelet count decreased
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Investigations
White blood cell decreased
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
6/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Paresthesia
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Lumps in arms
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Nervous system disorders
Cognitive disturbance
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
80.0%
8/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Psychiatric disorders
Depression
|
60.0%
6/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Nervous system disorders
Personality change
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Renal and urinary disorders
Hematuria
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Renal and urinary disorders
Urinary tract pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Renal and urinary disorders
Urinary urgency
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Dyspareunia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Menorrhagia
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
70.0%
7/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
80.0%
8/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
70.0%
7/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Vascular disorders
Hot flashes
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of study treatment and adverse events of clinical interest were followed through 90 days following the last day of study treatment (approximately 56 weeks). All-cause mortality was collected from start of treatment through completion of follow-up (median follow-up of 35 months, full range 11.3-46 months).
|
Additional Information
Premal Thaker, M.D., MSc.
Washington University School of Medicine
Phone: 314-362-1740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place