Trial Outcomes & Findings for Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer (NCT NCT02257528)
NCT ID: NCT02257528
Last Updated: 2025-09-08
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
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
The average of study treatment time was 3.8 months.
Results posted on
2025-09-08
Participant Flow
This study was activated on 5/18/2015 and closed to accrual on 6/8/2016.
Participant milestones
| Measure |
Treatment (Nivolumab)
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Nivolumab)
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Overall Study
Never received study treatment
|
1
|
Baseline Characteristics
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab)
n=25 Participants
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Age, Customized
20-29 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The average of study treatment time was 3.8 months.Population: Eligible and evaluable 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 |
Treatment (Nivolumab)
n=25 Participants
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Objective Tumor Response as Assessed by RECIST 1.1 Criteria
|
4 percentage of participants
Interval 0.9 to 100.0
|
PRIMARY outcome
Timeframe: Within 100 days of last protocol treatmentPopulation: Eligible and evaluable patients
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=25 Participants
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Vascular disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Leukopenia
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Thrombocytopenia
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Neutropenia
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Anemia
|
3 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Other Investigations
|
4 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Endocrine Disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Gastrointestinal disorders
|
5 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
General disorders & administration site conditions
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Hepatobiliary disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Infections and Infestations
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Metabolism and nutrition disorders
|
5 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Musculoskeletal and connective tissue disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Neoplasms benign, malignant and unspecified
|
2 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Other nervous system disorders
|
1 participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Reproductive system and breast disorders
|
1 participants
|
SECONDARY outcome
Timeframe: Time from study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up.Population: Eligible and Evaluable patients
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 |
Treatment (Nivolumab)
n=25 Participants
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Progression-free Survival
|
3.5 months
Interval 1.9 to 5.1
|
SECONDARY outcome
Timeframe: Time from study entry to time of death or the date of last contact, up to 5 years of follow-upPopulation: Eligible and evaluable 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 |
Treatment (Nivolumab)
n=25 Participants
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Overall Survival
|
14.5 months
Interval 8.3 to 26.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsSpearman's correlation coefficient will be used to explore the associations of tumor expressions of PD-L1, PD-1 and other interested biomarkers with tumor response. Cox proportional hazards (PH) model will be utilized to evaluate the associations of these tumor expressions with PFS and OS. These expressions may also be dichotomized into high versus low values (cut at the median). Log-rank tests will be used to assess the associations of these dichotomized tumor expressions with PFS and OS. The corresponding hazard rations will be estimated by Cox PH models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsImmune infiltration related biomarkers (i.e., CD4+, CD8+, FoxP3) in tumor specimens will be associated with objective tumor response, PFS and OS in nivolumab-treated patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 5 yearsWilcoxon signed rank test (for interval or ordinal data) or McNemar's test (for binary data) may be utilized to examine whether the study treatment will change immune response to HPV 16/18/31/35/45 E7 antigen in peripheral blood lymphocytes and serum by changes in the measures of pre- and post-treatment immune response to HPV 16/18/31/35/45 E7.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 12 weeksChange in the CTC count and whether the CTC count is associated with objective response, PFS and OS in nivolumab-treated patients will be evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Nivolumab)
Serious events: 12 serious events
Other events: 24 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab)
n=25 participants at risk
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Kidney Infection
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Serum Amylase Increased
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Vascular disorders
Thromboembolic Event
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
Other adverse events
| Measure |
Treatment (Nivolumab)
n=25 participants at risk
Patients were treated with 4 doses of IV nivolumab (3 mg/kg every 2 weeks), followed by an additional 42 doses 3 mg/kg every 2 weeks for a maximum of 46 doses until disease progression or adverse effects prohibit therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Blood and lymphatic system disorders
Anemia
|
56.0%
14/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Cardiac disorders
Palpitations
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Cardiac disorders
Sinus Tachycardia
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Endocrine disorders
Hyperthyroidism
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Endocrine disorders
Endocrine Disorders - Other
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Eye disorders
Conjunctivitis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Constipation
|
32.0%
8/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
6/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
9/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Bloating
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Stomach Pain
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
44.0%
11/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Nausea
|
48.0%
12/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Rectal Pain
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Gastrointestinal disorders
Flatulence
|
16.0%
4/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Pain
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Flu Like Symptoms
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Edema Limbs
|
32.0%
8/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Fatigue
|
60.0%
15/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Fever
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Chills
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
General disorders
Infusion Related Reaction
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Upper Respiratory Infection
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Vulval Infection
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Lung Infection
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Kidney Infection
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Vaginal Infection
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Infections and infestations
Urinary Tract Infection
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Injury, poisoning and procedural complications
Bruising
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Investigations - Other
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Weight Loss
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Serum Amylase Increased
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Platelet Count Decreased
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Lymphocyte Count Decreased
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Lipase Increased
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Creatinine Increased
|
24.0%
6/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Neutrophil Count Decreased
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Blood Bilirubin Increased
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
White Blood Cell Decreased
|
16.0%
4/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.0%
4/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Alkaline Phosphatase Increased
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Investigations
Alanine Aminotransferase Increased
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.0%
4/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.0%
4/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.0%
8/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.0%
7/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
20.0%
5/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
24.0%
6/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Nervous system disorders
Recurrent Laryngeal Nerve Palsy
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
24.0%
6/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Nervous system disorders
Headache
|
28.0%
7/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Nervous system disorders
Akathisia
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Psychiatric disorders
Anxiety
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Urinary Urgency
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Urinary Incontinence
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Urinary Frequency
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Urinary Fistula
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Hematuria
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Vaginal Fistula
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
6/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
8.0%
2/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Vascular disorders
Thromboembolic Event
|
12.0%
3/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
|
Vascular disorders
Hypertension
|
28.0%
7/25 • All Adverse Events (AEs) occurring during treatment and up to 5 years after are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60