Trial Outcomes & Findings for Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer (NCT NCT00436215)
NCT ID: NCT00436215
Last Updated: 2020-11-23
Results Overview
Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. 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 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 increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
patients were followed for a median of 18 weeks (range 1-116 weeks)
Results posted on
2020-11-23
Participant Flow
Participant milestones
| Measure |
BAY 43-9006 + Bevacizumab
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
BAY 43-9006 + Bevacizumab
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Overall Study
Refused further treatment
|
3
|
|
Overall Study
Small bowel obstruction
|
1
|
Baseline Characteristics
Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
BAY 43-9006 + Bevacizumab
n=55 Participants
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 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
|
|
Region of Enrollment
United States
|
55 Participants
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
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
56.37 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: patients were followed for a median of 18 weeks (range 1-116 weeks)Population: Seven patients were not evaluable for response assessment.
Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. 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 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 increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.
Outcome measures
| Measure |
BAY 43-9006 + Bevacizumab
n=48 Participants
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Clinical Response Rate.
Complete Response
|
0 percentage of participants
|
|
Clinical Response Rate.
Partial Response
|
19 percentage of participants
|
|
Clinical Response Rate.
Progressive Disease
|
21 percentage of participants
|
|
Clinical Response Rate.
Stable Disease
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: up to 28 monthsProgression free survival is defined by the number of weeks between the first day of treatment and the date of cancer progression.
Outcome measures
| Measure |
BAY 43-9006 + Bevacizumab
n=55 Participants
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Progression-free Survival
|
26 Weeks
Standard Deviation 24
|
SECONDARY outcome
Timeframe: up to 28 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
BAY 43-9006 + Bevacizumab
n=55 Participants
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Number of Participants With Adverse Events
|
54 Participants
|
Adverse Events
BAY 43-9006 + Bevacizumab
Serious events: 25 serious events
Other events: 54 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BAY 43-9006 + Bevacizumab
n=55 participants at risk
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
5/55 • Number of events 5 • up to 28 months
|
|
Immune system disorders
Allergic reaction
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Catheter related infection
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Cecal infection
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
General disorders
Fever
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Nervous system disorders
Headache
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify (bile duct obstruction)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Vascular disorders
Hypertension
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Nausea
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.7%
7/55 • Number of events 7 • up to 28 months
|
|
Vascular disorders
Thromboembolic event
|
7.3%
4/55 • Number of events 5 • up to 28 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Wound infection
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
Other adverse events
| Measure |
BAY 43-9006 + Bevacizumab
n=55 participants at risk
BAY 43-9006 (sorafenib) + Bevacizumab
Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks
BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Abdominal pain
|
25.5%
14/55 • Number of events 16 • up to 28 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
36.4%
20/55 • Number of events 38 • up to 28 months
|
|
Psychiatric disorders
Agitation
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Investigations
Alanine aminotransferase increased
|
54.5%
30/55 • Number of events 58 • up to 28 months
|
|
Investigations
Alkaline phosphatase increased
|
41.8%
23/55 • Number of events 46 • up to 28 months
|
|
Immune system disorders
Allergic reaction
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Immune system disorders
Allergic rhinitis
|
12.7%
7/55 • Number of events 8 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.9%
6/55 • Number of events 6 • up to 28 months
|
|
Gastrointestinal disorders
Anal fistula
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Anal mucositis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Anal pain
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Immune system disorders
Anaphylaxis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Blood and lymphatic system disorders
Anemia
|
23.6%
13/55 • Number of events 21 • up to 28 months
|
|
Infections and infestations
Anorectal infection
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Metabolism and nutrition disorders
Anorexia
|
30.9%
17/55 • Number of events 22 • up to 28 months
|
|
Psychiatric disorders
Anxiety
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Investigations
Aspartate aminotransferase increased
|
69.1%
38/55 • Number of events 65 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
9/55 • Number of events 10 • up to 28 months
|
|
Investigations
Blood bilirubin increased
|
18.2%
10/55 • Number of events 14 • up to 28 months
|
|
Eye disorders
Blurred vision
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Injury, poisoning and procedural complications
Bruising
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Injury, poisoning and procedural complications
Burn
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Investigations
CPK increased
|
5.5%
3/55 • Number of events 4 • up to 28 months
|
|
Eye disorders
Cataract
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Cheilitis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.5%
3/55 • Number of events 4 • up to 28 months
|
|
General disorders
Chills
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Constipation
|
16.4%
9/55 • Number of events 9 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
5/55 • Number of events 5 • up to 28 months
|
|
Investigations
Creatinine increased
|
18.2%
10/55 • Number of events 22 • up to 28 months
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
5/55 • Number of events 5 • up to 28 months
|
|
Psychiatric disorders
Depression
|
7.3%
4/55 • Number of events 5 • up to 28 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.9%
17/55 • Number of events 35 • up to 28 months
|
|
Nervous system disorders
Dizziness
|
10.9%
6/55 • Number of events 6 • up to 28 months
|
|
Eye disorders
Dry eye
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.3%
4/55 • Number of events 4 • up to 28 months
|
|
Nervous system disorders
Dysgeusia
|
18.2%
10/55 • Number of events 10 • up to 28 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.5%
8/55 • Number of events 8 • up to 28 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
5/55 • Number of events 5 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
32.7%
18/55 • Number of events 19 • up to 28 months
|
|
Eye disorders
Eye disorders - Other, specify
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
General disorders
Eye pain
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
General disorders
Fatigue
|
47.3%
26/55 • Number of events 28 • up to 28 months
|
|
General disorders
Fever
|
10.9%
6/55 • Number of events 8 • up to 28 months
|
|
Eye disorders
Flashing lights
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
General disorders
Flu like symptoms
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Vascular disorders
Flushing
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (early satiety)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (gastroenteritis)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Gingival pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Nervous system disorders
Headache
|
40.0%
22/55 • Number of events 30 • up to 28 months
|
|
Renal and urinary disorders
Hematuria
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
5.5%
3/55 • Number of events 4 • up to 28 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
5/55 • Number of events 5 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
18.2%
10/55 • Number of events 10 • up to 28 months
|
|
Vascular disorders
Hot flashes
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
11/55 • Number of events 17 • up to 28 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
5/55 • Number of events 5 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.9%
6/55 • Number of events 7 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
21.8%
12/55 • Number of events 15 • up to 28 months
|
|
Vascular disorders
Hypertension
|
54.5%
30/55 • Number of events 49 • up to 28 months
|
|
Endocrine disorders
Hyperthyroidism
|
16.4%
9/55 • Number of events 9 • up to 28 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.7%
7/55 • Number of events 10 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
74.5%
41/55 • Number of events 85 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.5%
3/55 • Number of events 4 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.9%
6/55 • Number of events 8 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.8%
23/55 • Number of events 50 • up to 28 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
56.4%
31/55 • Number of events 75 • up to 28 months
|
|
Endocrine disorders
Hypoparathyroidism
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
11/55 • Number of events 15 • up to 28 months
|
|
Vascular disorders
Hypotension
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Endocrine disorders
Hypothyroidism
|
7.3%
4/55 • Number of events 4 • up to 28 months
|
|
Infections and infestations
Infections and infestations - Other, specify (bronchitis)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Infections and infestations - Other, specify (oral candidasis/thrush)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Infections and infestations - Other, specify (pyuria)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Infections and infestations - Other, specify (unknown ANC)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Psychiatric disorders
Insomnia
|
10.9%
6/55 • Number of events 6 • up to 28 months
|
|
Investigations
Investigations - Other, specify
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Nervous system disorders
Lethargy
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Lip pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Investigations
Lipase increased
|
10.9%
6/55 • Number of events 13 • up to 28 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Investigations
Lymphocyte count decreased
|
47.3%
26/55 • Number of events 69 • up to 28 months
|
|
Nervous system disorders
Memory impairment
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Mucosal infection
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Mucositis oral
|
63.6%
35/55 • Number of events 59 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (cramps)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (muscle cramping)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.5%
8/55 • Number of events 8 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Nausea
|
32.7%
18/55 • Number of events 21 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Investigations
Neutrophil count decreased
|
5.5%
3/55 • Number of events 4 • up to 28 months
|
|
General disorders
Non-cardiac chest pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Gastrointestinal disorders
Oral pain
|
3.6%
2/55 • Number of events 3 • up to 28 months
|
|
General disorders
Pain
|
10.9%
6/55 • Number of events 6 • up to 28 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.4%
9/55 • Number of events 11 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
85.5%
47/55 • Number of events 104 • up to 28 months
|
|
Nervous system disorders
Paresthesia
|
1.8%
1/55 • Number of events 3 • up to 28 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
4/55 • Number of events 5 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Pharyngitis
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Phlebitis infective
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Investigations
Platelet count decreased
|
34.5%
19/55 • Number of events 27 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/55 • Number of events 2 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.6%
2/55 • Number of events 3 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Gastrointestinal disorders
Proctitis
|
5.5%
3/55 • Number of events 4 • up to 28 months
|
|
Renal and urinary disorders
Proteinuria
|
23.6%
13/55 • Number of events 18 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.5%
8/55 • Number of events 11 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
21.8%
12/55 • Number of events 15 • up to 28 months
|
|
Gastrointestinal disorders
Rash maculo-papular
|
16.4%
9/55 • Number of events 10 • up to 28 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Renal and urinary disorders
Rectal pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (dysuria)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (high blood urea nitrogen)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (WBC in urine)
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Renal and urinary disorders
Renal hemorrhage
|
1.8%
1/55 • Number of events 2 • up to 28 months
|
|
Infections and infestations
Rhinitis infective
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.6%
2/55 • Number of events 3 • up to 28 months
|
|
Investigations
Serum amylase increased
|
10.9%
6/55 • Number of events 12 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
23.6%
13/55 • Number of events 13 • up to 28 months
|
|
Infections and infestations
Sinusitis
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Infections and infestations
Skin infection
|
7.3%
4/55 • Number of events 4 • up to 28 months
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Gastrointestinal disorders
Stomach pain
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Tooth infection
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
11/55 • Number of events 12 • up to 28 months
|
|
Renal and urinary disorders
Urinary frequency
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Infections and infestations
Urinary tract infection
|
14.5%
8/55 • Number of events 9 • up to 28 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.6%
2/55 • Number of events 2 • up to 28 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Infections and infestations
Vaginal infection
|
5.5%
3/55 • Number of events 3 • up to 28 months
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
1/55 • Number of events 1 • up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
23.6%
13/55 • Number of events 13 • up to 28 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
11/55 • Number of events 16 • up to 28 months
|
|
Investigations
Weight gain
|
3.6%
2/55 • Number of events 3 • up to 28 months
|
|
Investigations
Weight loss
|
52.7%
29/55 • Number of events 44 • up to 28 months
|
|
Investigations
White blood cell decreased
|
18.2%
10/55 • Number of events 15 • up to 28 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place