Trial Outcomes & Findings for Ixabepilone to Treat Cervical Cancer (NCT NCT00924066)
NCT ID: NCT00924066
Last Updated: 2019-11-21
Results Overview
Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Every 6 weeks, up to 15 months
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
Squamous and Nonsquamous Participants
Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixabepilone to Treat Cervical Cancer
Baseline characteristics by cohort
| Measure |
Squamous and Nonsquamous Participants
n=41 Participants
Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.
|
|---|---|
|
Age, Continuous
|
46.79 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks, up to 15 monthsEstablish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.
Outcome measures
| Measure |
Squamous and Nonsquamous Participants
n=41 Participants
Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.
|
|---|---|
|
Number of Participants With a Tumor Response (PR + CR) Per RECIST
Stable Disease
|
10 Participants
|
|
Number of Participants With a Tumor Response (PR + CR) Per RECIST
Not Evaluable (only 1 cycle)
|
2 Participants
|
|
Number of Participants With a Tumor Response (PR + CR) Per RECIST
Progressive Disease
|
25 Participants
|
|
Number of Participants With a Tumor Response (PR + CR) Per RECIST
Partial Response
|
4 Participants
|
|
Number of Participants With a Tumor Response (PR + CR) Per RECIST
Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 61 monthsPopulation: Adverse events are grouped together because the histology cohort has no bearing on the adverse events.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Squamous and Nonsquamous Participants
n=41 Participants
Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.
|
|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
41 Participants
|
Adverse Events
Adverse Events for Squamous and Non-squamous Participants
Serious events: 18 serious events
Other events: 41 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Adverse Events for Squamous and Non-squamous Participants
n=41 participants at risk
Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Alkaline phosphatase increased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Blood and lymphatic system disorders
Anemia
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Catheter related infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Colonic fistula
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Death NOS
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Psychiatric disorders
Depression
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Fever
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Ileal fistula
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Ileus
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Joint infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Pain
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Phlebitis infective
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Vascular disorders
Thromboembolic event
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary fistula
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
Other adverse events
| Measure |
Adverse Events for Squamous and Non-squamous Participants
n=41 participants at risk
Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.
Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.
All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.5%
8/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Alanine aminotransferase increased
|
29.3%
12/41 • Number of events 26 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Alkaline phosphatase increased
|
51.2%
21/41 • Number of events 44 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Immune system disorders
Allergic reaction
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Immune system disorders
Allergic rhinitis
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.8%
11/41 • Number of events 14 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
41/41 • Number of events 256 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
46.3%
19/41 • Number of events 26 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.1%
7/41 • Number of events 11 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Aspartate aminotransferase increased
|
34.1%
14/41 • Number of events 27 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
4/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Blood bilirubin increased
|
12.2%
5/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Eye disorders
Blurred vision
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
CPK increased
|
9.8%
4/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Chills
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Colonic fistula
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Psychiatric disorders
Confusion
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Constipation
|
34.1%
14/41 • Number of events 18 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
3/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Creatinine increased
|
29.3%
12/41 • Number of events 31 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Psychiatric disorders
Depression
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Diarrhea
|
31.7%
13/41 • Number of events 21 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Dysgeusia
|
7.3%
3/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.1%
7/41 • Number of events 10 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Edema limbs
|
22.0%
9/41 • Number of events 12 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Edema trunk
|
4.9%
2/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Fatigue
|
56.1%
23/41 • Number of events 46 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Fever
|
19.5%
8/41 • Number of events 14 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Eye disorders
Flashing lights
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Gait disturbance
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Headache
|
12.2%
5/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Hematuria
|
12.2%
5/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
36.6%
15/41 • Number of events 35 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.2%
5/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.2%
5/41 • Number of events 9 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.3%
3/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
29.3%
12/41 • Number of events 24 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
75.6%
31/41 • Number of events 92 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
29.3%
12/41 • Number of events 18 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
43.9%
18/41 • Number of events 41 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
61.0%
25/41 • Number of events 79 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
53.7%
22/41 • Number of events 48 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
31.7%
13/41 • Number of events 32 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Infections and infestations - Other, specify (Toe nail W normal ANC)
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Infusion related reaction
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Investigations - Other, specify
|
9.8%
4/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
41/41 • Number of events 304 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Mucosal infection
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Mucositis oral
|
14.6%
6/41 • Number of events 6 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
5/41 • Number of events 7 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Nausea
|
61.0%
25/41 • Number of events 46 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Neuralgia
|
9.8%
4/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Neutrophil count decreased
|
19.5%
8/41 • Number of events 12 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Eye disorders
Optic nerve disorder
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
General disorders
Pain
|
7.3%
3/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.8%
4/41 • Number of events 4 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.9%
2/41 • Number of events 3 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.0%
9/41 • Number of events 14 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Platelet count decreased
|
61.0%
25/41 • Number of events 83 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Rectal fistula
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Rectal mucositis
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Rectal pain
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Rectal ulcer
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Cardiac disorders
Sinus tachycardia
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
12.2%
5/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary fistula
|
2.4%
1/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary frequency
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Infections and infestations
Urinary tract infection
|
19.5%
8/41 • Number of events 8 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.3%
3/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Renal and urinary disorders
Urinary urgency
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
4.9%
2/41 • Number of events 2 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.4%
1/41 • Number of events 1 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Gastrointestinal disorders
Vomiting
|
43.9%
18/41 • Number of events 32 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
Weight loss
|
12.2%
5/41 • Number of events 5 • Date treatment consent signed to date off study, approximately 61 months.
|
|
Investigations
White blood cell decreased
|
43.9%
18/41 • Number of events 75 • Date treatment consent signed to date off study, approximately 61 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place