Trial Outcomes & Findings for Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer (NCT NCT01676818)
NCT ID: NCT01676818
Last Updated: 2025-11-06
Results Overview
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months
Results posted on
2025-11-06
Participant Flow
The study was opened to accrual in August 2012 and closed in April 2018. All patients were seen and treated at USC Norris Comprehensive Cancer Center and/or at Los Angeles County + University of Southern California Medical Center.
The study has no pre-assignment criteria.
Participant milestones
| Measure |
Eribulin Mesylate
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Eribulin Mesylate
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate
n=32 Participants
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=49 Participants
|
|
Disease Type
Adenocarcinoma
|
8 Participants
n=49 Participants
|
|
Disease Type
Adenosquamous Carcinoma
|
1 Participants
n=49 Participants
|
|
Disease Type
Small Cell Carcinoma
|
1 Participants
n=49 Participants
|
|
Disease Type
Squamous Cell Carcinoma
|
22 Participants
n=49 Participants
|
|
Disease Status
Recurrent
|
21 Participants
n=49 Participants
|
|
Disease Status
Advanced
|
11 Participants
n=49 Participants
|
|
Patient Received Prior Chemotherapy
Yes
|
29 Participants
n=49 Participants
|
|
Patient Received Prior Chemotherapy
No
|
3 Participants
n=49 Participants
|
|
Received Prior Regimens
Cisplatin + Paclitaxel + Bevacizumab
|
12 Participants
n=49 Participants
|
|
Received Prior Regimens
Cisplatin + Gemcitabine
|
12 Participants
n=49 Participants
|
|
Received Prior Regimens
Carboplatin + Paclitaxel
|
2 Participants
n=49 Participants
|
|
Received Prior Regimens
Cisplatin with/without Premetrexed or Capecitabine only
|
3 Participants
n=49 Participants
|
|
Received Prior Regimens
No Prior Regimen
|
3 Participants
n=49 Participants
|
|
Received Prior Paclitaxel (PTX)
Yes
|
14 Participants
n=49 Participants
|
|
Received Prior Paclitaxel (PTX)
No
|
18 Participants
n=49 Participants
|
|
Received Prior Radiation Therapy
Yes
|
28 Participants
n=49 Participants
|
|
Received Prior Radiation Therapy
No
|
4 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 monthsPopulation: All participants are included
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Outcome measures
| Measure |
Eribulin Mesylate
n=32 Participants
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Progression-free Survival
|
2.5 Months
Interval 1.2 to 4.2
|
PRIMARY outcome
Timeframe: At study drug administration until 30 days following the last dose. Assessed up to 2 years.Population: All patients who were enrolled and treated with at least 1 dose of the study drug were assessed for safety.
Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 was used to grade all SAEs. Grade 3+ hematologic and non-hematologic toxicities are reported.
Outcome measures
| Measure |
Eribulin Mesylate
n=32 Participants
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
25 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeks from start of treatment until occurrence of progressive disease, assessed up to 4 years.Population: All patients who received at least 1 cycle of treatment are included. 2 patients were excluded due to not being evaluated.
BOR is defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Eribulin Mesylate
n=30 Participants
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Best Overall Response (BOR)
Complete Response
|
1 Participants
|
|
Best Overall Response (BOR)
Partial Response
|
5 Participants
|
|
Best Overall Response (BOR)
Stable Disease
|
13 Participants
|
|
Best Overall Response (BOR)
Progressive Disease
|
11 Participants
|
SECONDARY outcome
Timeframe: From first day of treatment to time of death due to any cause, assessed up to 2 yearsOverall survival is defined as the time from first day of treatment to time of death due to any cause. If a patient is still alive, survival time is censored at the time of last follow-up.
Outcome measures
| Measure |
Eribulin Mesylate
n=32 Participants
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Overall Survival (OS)
|
6.5 Months
Interval 4.5 to 12.7
|
Adverse Events
Eribulin Mesylate
Serious events: 25 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eribulin Mesylate
n=32 participants at risk
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
14/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Aspartate Aminotransferase increased
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Hematuria
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Vascular disorders
Hypotension
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Neutrophil count decreased
|
21.9%
7/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Paresthesia
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Platelet count decreased
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Sepsis
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Skin infection
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Upper respiratory infection
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
White blood cell decreased
|
18.8%
6/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
Other adverse events
| Measure |
Eribulin Mesylate
n=32 participants at risk
Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
16/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
21.9%
7/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Alkaline phosphatase increased
|
40.6%
13/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
84.4%
27/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Anal pain
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Blood and lymphatic system disorders
Anemia
|
90.6%
29/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
81.2%
26/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Psychiatric disorders
Anxiety
|
18.8%
6/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.8%
14/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Aspartate Aminotransferase increased
|
21.9%
7/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
62.5%
20/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Bloating
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Eye disorders
Blurred vision
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.1%
9/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Injury, poisoning and procedural complications
Burn
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Chills
|
40.6%
13/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
75.0%
24/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.6%
13/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Creatinine increased
|
15.6%
5/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
21.9%
7/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Psychiatric disorders
Depression
|
15.6%
5/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
14/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Dizziness
|
56.2%
18/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Eye disorders
Dry eye
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Dysgeusia
|
28.1%
9/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
6/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.2%
10/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Edema limbs
|
46.9%
15/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Eye disorders
Eye pain
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Fatigue
|
96.9%
31/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Fever
|
31.2%
10/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized weakness
|
50.0%
16/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Headache
|
31.2%
10/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Hematuria
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Vascular disorders
Hot flashes
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.1%
9/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.6%
5/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
6/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Psychiatric disorders
Insomnia
|
34.4%
11/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
46.9%
15/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.1%
9/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
90.6%
29/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Neutrophil count decreased
|
31.2%
10/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
General disorders
Pain
|
18.8%
6/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
62.5%
20/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Papulopustular rash
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Paresthesia
|
62.5%
20/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Reproductive system and breast disorders
Pelvic pain
|
21.9%
7/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Platelet count decreased
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Proctitis
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.6%
5/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
28.1%
9/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Rectal pain
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Skin infection
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
2/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
4/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Upper respiratory infection
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Urinary frequency
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Infections and infestations
Urinary tract infection
|
18.8%
6/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
15.6%
5/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
21.9%
7/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Reproductive system and breast disorders
Vaginal pain
|
9.4%
3/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
62.5%
20/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Eye disorders
Watering eyes
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
Weight loss
|
37.5%
12/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
1/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
|
Investigations
White blood cell decreased
|
46.9%
15/32 • Adverse events were collected from the time the subject received the initial study drug administration and continued until 30 days after the last dose or until resolution of adverse event if beyond 30 days after last dose. Assessed up to 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place