Trial Outcomes & Findings for Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer (NCT NCT01210222)
NCT ID: NCT01210222
Last Updated: 2018-02-23
Results Overview
Whether or not the patient survived progression-free for at least 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
At 6 months
Results posted on
2018-02-23
Participant Flow
GOG 0229L accrued 35 patients from June 2011 to August 2012. 32 of these patients were eligible.
Participant milestones
| Measure |
Treatment (Trebananib)
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Trebananib)
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
|---|---|
|
Overall Study
Ineligible
|
2
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Trebananib)
n=32 Participants
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
|---|---|
|
Age, Customized
40 - 49 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
70 - 79 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Eligible and treated patients
Whether or not the patient survived progression-free for at least 6 months.
Outcome measures
| Measure |
Treatment (Trebananib)
n=32 Participants
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival > 6 Months
|
18.8 percentage of participants
Interval 8.5 to 33.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and treated patients.
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Trebananib)
n=32 Participants
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Objective Tumor Response (Complete or Partial Response)
|
3.1 percentage of participants
Interval 0.2 to 14.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and evaluable patients
Outcome measures
| Measure |
Treatment (Trebananib)
n=32 Participants
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
Grade 1 (CTCAE v 4.0)
n=32 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
n=32 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
n=32 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
n=32 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
n=32 Participants
Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Fatigue
|
10 Participants
|
11 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Anemia
|
15 Participants
|
15 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Constipation
|
16 Participants
|
10 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Hypertension
|
20 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Nausea
|
20 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Abdominal Pain
|
20 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Edema Limbs
|
21 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Anorexia
|
22 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Peripheral Sensory Neuropathy
|
22 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Cough
|
24 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Diarrhea
|
24 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Hyperglycemia
|
24 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Hyponatremia
|
24 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Hypoalbuminemia
|
24 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Dyspnea
|
25 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Vomiting
|
25 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Ascites
|
27 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Bloating
|
28 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Lymphedema
|
28 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Thromboembolic Event
|
28 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events as Assessed by NCI CTCAE v 4.0
Localized Edema
|
29 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 yearsPopulation: Eligible and treated patients
The observed length of life from entry into the study to death or the date of last contact.
Outcome measures
| Measure |
Treatment (Trebananib)
n=32 Participants
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
6.6 Months
Interval 4.01 to 14.75
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients whose disease can be evaluated by physical exam, progression was assessed prior to each cycle. CT or MRI if used to follow leasion for measurable disease, up to 5 yearsPopulation: Eligible and treated patients
The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Trebananib)
n=32 Participants
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
2.0 Months
Interval 1.77 to 2.1
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (Trebananib)
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Trebananib)
n=32 participants at risk
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
|---|---|
|
Gastrointestinal disorders
Colonic Obstruction
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Limbs
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Death Nos
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Kidney Infection
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
Pneumothorax
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thromboembolic Event
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Lymphedema
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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 |
Treatment (Trebananib)
n=32 participants at risk
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Trebananib: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
53.1%
17/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Palpitations
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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 Impaired
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Eye Disorders - Other
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Watering Eyes
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Eyelid Function Disorder
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
6/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
16/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
8/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
7/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Bloating
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.1%
9/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Mucositis Oral
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ileus
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Oral Cavity Fistula
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
12/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Rectal Pain
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ascites
|
15.6%
5/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Localized Edema
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Irritability
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Flu Like Symptoms
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Trunk
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Limbs
|
31.2%
10/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Face
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fatigue
|
68.8%
22/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fever
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Chills
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Bronchial Infection
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Investigations - Other
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Weight Loss
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Weight Gain
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Platelet Count Decreased
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Lymphocyte Count Decreased
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Inr Increased
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Hemoglobin Increased
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Ggt Increased
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Creatinine Increased
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
White Blood Cell Decreased
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alkaline Phosphatase Increased
|
21.9%
7/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
25.0%
8/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
15.6%
5/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
15.6%
5/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
15.6%
5/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
25.0%
8/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
25.0%
8/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
10/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
15.6%
5/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.8%
6/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
31.2%
10/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Lethargy
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Movements Involuntary
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Facial Muscle Weakness
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
15.6%
5/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Suicidal Ideation
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Hallucinations
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Depression
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Anxiety
|
18.8%
6/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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 Urgency
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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 Incontinence
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Hematuria
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
Sore Throat
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
Pneumothorax
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
Pleural Effusion
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.2%
2/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
21.9%
7/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
|
25.0%
8/32 • AEs were collected during treatment and up to 30 days after study treatment ended. 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
Wheezing
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thromboembolic Event
|
12.5%
4/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Phlebitis
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Lymphedema
|
9.4%
3/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hypertension
|
37.5%
12/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hot Flashes
|
3.1%
1/32 • AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60