Trial Outcomes & Findings for Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer (NCT NCT01267253)
NCT ID: NCT01267253
Last Updated: 2019-03-20
Results Overview
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Results posted on
2019-03-20
Participant Flow
Participant milestones
| Measure |
Brivanib
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Brivanib
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Overall Study
Ineligible - required test not done
|
1
|
|
Overall Study
Inevaluable-never received study treatme
|
2
|
Baseline Characteristics
Brivanib Alaninate in Treating Patients With Persistent or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Brivanib
n=28 Participants
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Age, Customized
30-39 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.Population: Eligible and Treated participants
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1
Outcome measures
| Measure |
Brivanib
n=28 Participants
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Objective Tumor Response
|
0.071 proportion
Interval 0.02 to 1.0
|
PRIMARY outcome
Timeframe: Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive diseasePopulation: Eligible and treated participants
Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.
Outcome measures
| Measure |
Brivanib
n=28 Participants
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry.
|
0.179 proportion
Interval 0.09 to 1.0
|
PRIMARY outcome
Timeframe: During treatment period and up to 30 days after stopping the study treatment.Population: Eligible and Treated Participants
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0
Outcome measures
| Measure |
Brivanib
n=28 Participants
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Leukopenia
|
0 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Thrombocytopenia
|
0 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Neutropenia
|
0 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Anemia
|
4 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Other Investigations
|
4 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Cardiac Disorders
|
1 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Gastrointestinal Disorders
|
7 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
General disorders & administration site conditions
|
2 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Hepatobiliary Disorders
|
1 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Infections and infestations
|
4 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Metabolism and nutrition disorders
|
5 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Musculoskeletal & connective tissue disorders
|
3 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Neoplasms benign, malignant & unspecified
|
2 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Nervous system disorders
|
3 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Renal and urinary disorders
|
2 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Vascular Disorders
|
5 Participants
|
SECONDARY outcome
Timeframe: From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-upPopulation: Eligible and Treated Participants
Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1
Outcome measures
| Measure |
Brivanib
n=28 Participants
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Progression-free Survival
|
3.2 Months
Interval 2.0 to 4.4
|
SECONDARY outcome
Timeframe: From study entry to time of death or the date of last contact, up to 5 years of follow-up.Population: Eligible and Treated Patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact..
Outcome measures
| Measure |
Brivanib
n=28 Participants
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Overall Survival
|
7.9 Months
Interval 6.1 to 11.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsSurrogate markers will be associated with response, PFS, and OS.
Outcome measures
Outcome data not reported
Adverse Events
Brivanib
Serious events: 14 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brivanib
n=28 participants at risk
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Pulmonary Valve Disease
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Colonic Hemorrhage
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis Oral
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Lung Infection
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Retention
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Other adverse events
| Measure |
Brivanib
n=28 participants at risk
Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
82.1%
23/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Sinus Tachycardia
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Endocrine disorders
Hyperthyroidism
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Eye Disorders - Other
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Photophobia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Blurred Vision
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
32.1%
9/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
39.3%
11/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomiting
|
53.6%
15/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Bloating
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
35.7%
10/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis Oral
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
20/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Rectal Pain
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Toothache
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain
|
17.9%
5/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Flu Like Symptoms
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Non-Cardiac Chest Pain
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Edema Limbs
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fatigue
|
78.6%
22/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fever
|
17.9%
5/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Chills
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Allergic Reaction
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Tooth Infection
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Skin Infection
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
17.9%
5/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Abdominal Infection
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Weight Loss
|
21.4%
6/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Weight Gain
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Platelet Count Decreased
|
28.6%
8/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Lymphocyte Count Decreased
|
17.9%
5/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Hemoglobin Increased
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Ejection Fraction Decreased
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Creatinine Increased
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Cardiac Troponin T Increased
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Neutrophil Count Decreased
|
17.9%
5/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Blood Bilirubin Increased
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
White Blood Cell Decreased
|
42.9%
12/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Aspartate Aminotransferase Increased
|
28.6%
8/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Alkaline Phosphatase Increased
|
25.0%
7/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Investigations
Alanine Aminotransferase Increased
|
25.0%
7/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.7%
10/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
6/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
8/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
8/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.1%
9/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
8/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
53.6%
15/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
32.1%
9/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Seizure
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
28.6%
8/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Memory Impairment
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Headache
|
39.3%
11/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dizziness
|
21.4%
6/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Concentration Impairment
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Aphonia
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Insomnia
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Hallucinations
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Depression
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Psychiatric disorders
Anxiety
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Urgency
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Frequency
|
21.4%
6/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Proteinuria
|
21.4%
6/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Hemoglobinuria
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Hematuria
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
7/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
3.6%
1/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Lymphedema
|
7.1%
2/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hypertension
|
42.9%
12/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hot Flashes
|
10.7%
3/28 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place