Trial Outcomes & Findings for Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT01132820)
NCT ID: NCT01132820
Last Updated: 2019-08-08
Results Overview
Adverse Events (Grade 3 or higher)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2019-08-08
Participant Flow
The study was activated on 6/7/2010 and suspended to accrual on 3/7/2011. The study reopened on 11/21/2011 and closed on 4/30/2012.
Participant milestones
| Measure |
Cediranib
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Cediranib
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
Ineligible: wrong cell type
|
1
|
|
Overall Study
Ineligible:Improper pre-protocol therapy
|
1
|
|
Overall Study
Ineligible:Inadequate pathology
|
1
|
|
Overall Study
Never treated
|
1
|
|
Overall Study
Inadequate data
|
1
|
Baseline Characteristics
Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Age, Customized
20-29 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
20 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and treated patients
Adverse Events (Grade 3 or higher)
Outcome measures
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Leukopenia
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Thrombocytopenia
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Neutropenia
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Anemia
|
3 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Other Investigations
|
4 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Other Blood/Lymphatics
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Cardiac
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Ear and labyrinth
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Endocrine
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Eye
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Nausea
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Vomiting
|
4 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Other Gastrointestinal
|
16 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
General and administration site
|
13 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Hepatobiliary
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Infections/infestations
|
6 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Injury/poisoning
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Metabolism/nutrition
|
8 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Musculoskeletal/connective tissue
|
3 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Neoplasms benign/malignant
|
4 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Peripheral sensory neuropathy
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Nervous system
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Psychiatric
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Renal/urinary
|
3 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Reproductive/breast
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Respiratory/thoracic/mediastinal
|
4 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Skin/subcutaneous
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0
Vascular disorders
|
18 Participants
|
PRIMARY outcome
Timeframe: For diesease evaluated by physical examination, response was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle from enrollment until stopping study therapy. The average time on study is 3 mnthsPopulation: Eligible and Treated Patients
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.
Outcome measures
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Tumor Response
|
12.5 percentage of participants
Interval 6.0 to 23.0
|
PRIMARY outcome
Timeframe: For disease evaluated by physical examination, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. Evaluated from time of enrollment until progression or death, up to 5 yearsPopulation: Eligible and Treated Patients
Number of participants who survived for at least 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Progression-free Survival (PFS) = > 6 Months
|
33.3 percentage of participants
Interval 22.0 to 46.0
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years.Population: Eligible and Treated Patients
The observed length of life from entry into the study to death or the date of last contact.
Outcome measures
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Survival
|
12.5 months
Interval 6.6 to 16.7
|
SECONDARY outcome
Timeframe: Disease that can be assessed by physical exam should be evaluated every cycle. disease assessed by imaging should be evaluated every other cycle. Time frame to determine the date of progression is from the date of enrollment up to 5 years after enrollmentPopulation: All eligible and evaluable patients
Time until disease progression, death, or date of last contact.
Outcome measures
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Progression Free Survival
|
3.61 Months
Interval 2.46 to 5.22
|
SECONDARY outcome
Timeframe: Tumor responses with time restriction starts at enrollment and goes to 6 months after enrollment or until pt. off study therapy,whichever occurs first. Without time restriction starts at enrollment,lasts until off study therapy, median duration = 2.63 mthPopulation: Eligible and Treated Patients
Complete and partial tumor response by RECIST 1.1
Outcome measures
| Measure |
Cediranib
n=48 Participants
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Response Without Regard to the Time of Documented Response
|
12.5 percentage of participants
Interval 6.0 to 23.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineHigh vs low expression.
Outcome measures
Outcome data not reported
Adverse Events
Cediranib
Serious events: 20 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cediranib
n=48 participants at risk
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Colonic Perforation
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Rectal Fistula
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Peritoneal Necrosis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ileal Obstruction
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Multi-Organ Failure
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Death Nos
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Lung Infection
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Bladder Infection
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Confusion
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thromboembolic Event
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Other adverse events
| Measure |
Cediranib
n=48 participants at risk
Cediranib (RECENTIN; AZD2171) will be administered PO 30 mg daily. Each 28 day period will be considered a cycle. Treatment will continue until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
35.4%
17/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Sinus Bradycardia
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
29.2%
14/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Endocrine disorders
Endocrine Disorders - Other
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Eye Disorders - Other
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Conjunctivitis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Blurred Vision
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Dry Eye
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
8/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Constipation
|
27.1%
13/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
68.8%
33/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
15/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.9%
11/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Mucositis Oral
|
29.2%
14/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Oral Pain
|
10.4%
5/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Nausea
|
45.8%
22/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Rectal Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Esophageal Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
General Disorders And Administration Site Conditio
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain
|
20.8%
10/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Flu Like Symptoms
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Limbs
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Face
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fatigue
|
81.2%
39/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fever
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Gait Disturbance
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Chills
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Gallbladder Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Upper Respiratory Infection
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Skin Infection
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
20.8%
10/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Investigations - Other
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Weight Loss
|
33.3%
16/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Platelet Count Decreased
|
22.9%
11/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Lymphocyte Count Decreased
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Lipase Increased
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Inr Increased
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Hemoglobin Increased
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Creatinine Increased
|
22.9%
11/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Cholesterol High
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Neutrophil Count Decreased
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Blood Bilirubin Increased
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
White Blood Cell Decreased
|
22.9%
11/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
12/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alkaline Phosphatase Increased
|
14.6%
7/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
18.8%
9/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.8%
10/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.8%
9/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
9/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.6%
7/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.8%
9/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
8/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
5/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
47.9%
23/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
6/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
31.2%
15/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Memory Impairment
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Headache
|
22.9%
11/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Dizziness
|
10.4%
5/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Cognitive Disturbance
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Insomnia
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Depression
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Anxiety
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
20.8%
10/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Hematuria
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Breast Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
10.4%
5/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.6%
7/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
8.3%
4/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
2/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thromboembolic Event
|
6.2%
3/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hypertension
|
60.4%
29/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hot Flashes
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hematoma
|
2.1%
1/48 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60