Trial Outcomes & Findings for Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT00888173)
NCT ID: NCT00888173
Last Updated: 2017-12-06
Results Overview
Whether or not the patient survived progression-free for at least 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
For patients whose disease can be evaluated by physical examination, progression was assessed prior to each cycle for 6 months.
Results posted on
2017-12-06
Participant Flow
The study was activated on 7/6/2009 and suspended to accrual on 12/14/2009. The study reopened on 9/7/2010 and closed on 1/3/2011.
Participant milestones
| Measure |
Brivanib
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Brivanib
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
Wrong Primary
|
1
|
|
Overall Study
Ineligible: required test not done
|
1
|
Baseline Characteristics
Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Brivanib
n=43 Participants
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Age, Continuous
|
64.3 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
|
12 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
15 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For patients whose disease can be evaluated by physical examination, progression was assessed prior to each cycle for 6 months.Population: Eligible and Treated Patients
Whether or not the patient survived progression-free for at least 6 months.
Outcome measures
| Measure |
Brivanib
n=43 Participants
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Progression-free Survival > 6 Months
|
30.2 percentage of participants
Interval 19.0 to 44.0
|
PRIMARY outcome
Timeframe: If evaluated by physical exam, response was assessed prior to each cycle. If evaluated by CT or MRI, response was assessed during course of therapy. Overall time frame is up to 6 months.Population: Eligible and Treated Patients
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 |
Brivanib
n=43 Participants
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Tumor Response
|
18.6 percentage of participants
Interval 9.0 to 31.0
|
SECONDARY outcome
Timeframe: From entry into the study to death or the date of last contact, assessed up to 5 yearsPopulation: Eligible and Treated Patients
Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on overall survival will be examined.
Outcome measures
| Measure |
Brivanib
n=43 Participants
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Duration of Overall Survival
|
10.7 months
Interval 9.2 to 18.1
|
SECONDARY outcome
Timeframe: Form study entry until disease progression, death or date of last contact, assessed up to 5 yearsPopulation: Eligible and Treated Patients
Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on progression-free survival will be examined.
Outcome measures
| Measure |
Brivanib
n=43 Participants
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Duration of Progression-free Survival
|
3.3 months
Interval 2.0 to 3.8
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and Treated Patients
Adverse Events (grade 3 or higher)
Outcome measures
| Measure |
Brivanib
n=43 Participants
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Leukopenia
|
1 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Anemia
|
2 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Cardiac
|
9 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Coagulation
|
5 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Constitutional
|
2 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Dermatologic
|
1 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Gastrointestinal
|
12 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Genitourinary/Renal
|
1 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Infection
|
2 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Lymphatics
|
2 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Metabolic
|
10 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Musculoskeletal
|
2 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Other Neurological
|
4 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Pain
|
4 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Vascular
|
2 Participants
|
|
Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria
Death, Not CTC coded
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill be correlated with clinical measures of outcome such as tumor response, progression-free survival (PFS), and endometrioid histology.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to pre-course 3Will be correlated with PFS, OS, tumor response, and histologic cell type.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill be correlated with PFS, OS, tumor response, and histologic cell type.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill be correlated with PFS, overall survival (OS), tumor response, and histologic cell type.
Outcome measures
Outcome data not reported
Adverse Events
Brivanib
Serious events: 18 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brivanib
n=43 participants at risk
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Cardiac disorders
Hypertension
|
4.7%
2/43 • 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
Inr
|
2.3%
1/43 • 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 No Ctcae Term - Disease Progression Nos
|
2.3%
1/43 • 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 No Ctcae Term - Multi-Organ Failure
|
2.3%
1/43 • 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
Fistula, Gi - Rectum
|
2.3%
1/43 • 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
Obstruction, Gi - Small Bowel Nos
|
4.7%
2/43 • 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
|
2.3%
1/43 • 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
|
4.7%
2/43 • 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
|
4.7%
2/43 • 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
Musculoskeletal/St: Other
|
2.3%
1/43 • 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 - Whole Body/Generalized
|
2.3%
1/43 • 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
Mental Status
|
2.3%
1/43 • 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
Somnolence
|
2.3%
1/43 • 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: Tumor
|
2.3%
1/43 • 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
Obstruction, Gu - Bladder
|
2.3%
1/43 • 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
Thrombosis/Thrombus/Embolism
|
4.7%
2/43 • 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 |
Brivanib
n=43 participants at risk
Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Immune system disorders
Rhinitis
|
7.0%
3/43 • 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
Otitis Middle Ear
|
2.3%
1/43 • 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
Otitis External Ear
|
2.3%
1/43 • 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
Hearing (Without Monitoring Program)
|
2.3%
1/43 • 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
|
2.3%
1/43 • 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
Neutrophils
|
9.3%
4/43 • 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
Platelets
|
23.3%
10/43 • 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
Leukocytes
|
32.6%
14/43 • 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
Lymphopenia
|
7.0%
3/43 • 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
Hemoglobin
|
48.8%
21/43 • 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
Palpitations
|
4.7%
2/43 • 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
Ventricular Arrhythmia - Fibrillation
|
2.3%
1/43 • 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
Hypertension
|
30.2%
13/43 • 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
Lt Ventricular Systolic Dysfunction
|
4.7%
2/43 • 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
Cardiac General - Other
|
2.3%
1/43 • 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
Inr
|
11.6%
5/43 • 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
Ptt
|
4.7%
2/43 • 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
Constitutional Symptoms - Other
|
2.3%
1/43 • 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
|
2.3%
1/43 • 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
Weight Loss
|
14.0%
6/43 • 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
|
65.1%
28/43 • 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
Insomnia
|
2.3%
1/43 • 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
Nail Changes
|
9.3%
4/43 • 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
Hair Loss/Alopecia (Scalp Or Body)
|
11.6%
5/43 • 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
Induration
|
2.3%
1/43 • 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
Bruising
|
2.3%
1/43 • 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
|
18.6%
8/43 • 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
|
2.3%
1/43 • 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
|
2.3%
1/43 • 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
Flushing
|
4.7%
2/43 • 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
Hand-Foot
|
4.7%
2/43 • 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
Dermatology/Skin - Other
|
2.3%
1/43 • 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
Hyperpigmentation
|
2.3%
1/43 • 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
|
7.0%
3/43 • 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
|
7.0%
3/43 • 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
|
2.3%
1/43 • 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
Heartburn
|
7.0%
3/43 • 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
Dental: Teeth
|
2.3%
1/43 • 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
|
2.3%
1/43 • 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
|
11.6%
5/43 • 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
Distention
|
4.7%
2/43 • 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
Incontinence, Anal
|
2.3%
1/43 • 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
|
2.3%
1/43 • 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 (Functional/Sympt) - Oral Cavity
|
20.9%
9/43 • 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 (Clinical Exam) - Oral Cavity
|
9.3%
4/43 • 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
|
25.6%
11/43 • 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
Anorexia
|
44.2%
19/43 • 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
Dehydration
|
4.7%
2/43 • 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
|
30.2%
13/43 • 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
|
62.8%
27/43 • 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 - Other
|
2.3%
1/43 • 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
|
44.2%
19/43 • 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
Hemorrhage, Gu - Urinary Nos
|
2.3%
1/43 • 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
Hemorrhage, Gu - Vagina
|
9.3%
4/43 • 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
Hemorrhage, Gi - Rectum
|
2.3%
1/43 • 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
Hemorrhage/Pulmonary - Nose
|
2.3%
1/43 • 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
Hepatobiliary/Pancreas - Other
|
2.3%
1/43 • 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
Inf W/Nml Or Gr 1 Or 2 Anc: Bone
|
2.3%
1/43 • 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
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
2.3%
1/43 • 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
Inf Unknown Anc: Sinus
|
4.7%
2/43 • 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
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
9.3%
4/43 • 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
Infection - Other
|
4.7%
2/43 • 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
Inf Unknown Anc: Upper Airway Nos
|
2.3%
1/43 • 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
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
7.0%
3/43 • 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
Inf Unknown Anc: Urinary Tract Nos
|
7.0%
3/43 • 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
Inf W/Gr 3 Or 4 Anc: Bone (Osteomyelitis)
|
2.3%
1/43 • 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
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
4.7%
2/43 • 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
Inf W/Nml Or Gr 1 Or 2 Anc: External Ear
|
2.3%
1/43 • 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
Edema: Limb
|
9.3%
4/43 • 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
Ast
|
51.2%
22/43 • 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
Gfr
|
2.3%
1/43 • 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
Proteinuria
|
11.6%
5/43 • 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
Creatinine
|
20.9%
9/43 • 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
|
20.9%
9/43 • 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
Alt
|
51.2%
22/43 • 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
Alkaline Phosphatase
|
32.6%
14/43 • 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
Bilirubin
|
2.3%
1/43 • 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
Hypermagnesemia
|
4.7%
2/43 • 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
|
30.2%
13/43 • 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
Hyperuricemia
|
2.3%
1/43 • 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
Bicarbonate, Serum-Low
|
7.0%
3/43 • 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
|
2.3%
1/43 • 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
|
18.6%
8/43 • 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
|
16.3%
7/43 • 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
|
37.2%
16/43 • 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
|
16.3%
7/43 • 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
|
4.7%
2/43 • 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
Hypercalcemia
|
7.0%
3/43 • 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
|
14.0%
6/43 • 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
Musculoskeletal/St: Other
|
4.7%
2/43 • 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
Fracture
|
2.3%
1/43 • 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
Arthritis
|
2.3%
1/43 • 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 - Whole Body/Generalized
|
2.3%
1/43 • 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 - Extremity-Lower
|
2.3%
1/43 • 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
Psychosis
|
4.7%
2/43 • 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
Mood Alteration - Euphoria
|
4.7%
2/43 • 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
Mood Alteration - Depression
|
7.0%
3/43 • 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
Mood Alteration - Anxiety
|
7.0%
3/43 • 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
Tremor
|
2.3%
1/43 • 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
Speech Impairment
|
2.3%
1/43 • 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
|
2.3%
1/43 • 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
Ataxia
|
2.3%
1/43 • 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
Confusion
|
7.0%
3/43 • 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
|
2.3%
1/43 • 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
|
20.9%
9/43 • 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
Neuropathy,cranial - Cn Xii Motor-Tongue
|
2.3%
1/43 • 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
Neuropathy-Sensory
|
32.6%
14/43 • 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
Neuropathy-Motor
|
2.3%
1/43 • 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
Flashing Lights/Floaters
|
2.3%
1/43 • 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
|
7.0%
3/43 • 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: Pelvis
|
2.3%
1/43 • 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: Chest /Thorax Nos
|
2.3%
1/43 • 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: Chest Wall
|
4.7%
2/43 • 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: Throat/Pharynx/Larynx
|
4.7%
2/43 • 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: Head/Headache
|
34.9%
15/43 • 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: Extremity-Limb
|
16.3%
7/43 • 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: Back
|
20.9%
9/43 • 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: Joint
|
14.0%
6/43 • 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: Kidney
|
2.3%
1/43 • 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: Stomach
|
2.3%
1/43 • 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: Oral Cavity
|
2.3%
1/43 • 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: Abdominal Pain Nos
|
25.6%
11/43 • 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: Skin
|
2.3%
1/43 • 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: Middle Ear
|
4.7%
2/43 • 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: External Ear
|
4.7%
2/43 • 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: Liver
|
2.3%
1/43 • 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: Muscle
|
4.7%
2/43 • 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: Neuralgia
|
2.3%
1/43 • 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/Paranasal Reactions
|
2.3%
1/43 • 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 Changes
|
7.0%
3/43 • 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
|
18.6%
8/43 • 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
|
20.9%
9/43 • 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
Perforation, Gu - Bladder
|
2.3%
1/43 • 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
Cystitis
|
2.3%
1/43 • 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 Retention
|
2.3%
1/43 • 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
Incontinence, Urinary
|
2.3%
1/43 • 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
Renal Failure
|
2.3%
1/43 • 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 Frequency
|
7.0%
3/43 • 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 Discharge
|
2.3%
1/43 • 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