Trial Outcomes & Findings for Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery (NCT NCT00316862)
NCT ID: NCT00316862
Last Updated: 2018-05-08
Results Overview
A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2018-05-08
Participant Flow
Between February 2006 and August 2011, 82 participants were recruited to this study.
Participant milestones
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
n=82 Participants
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Age, Continuous
|
62.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: 27 participants with adenocarcinoma were recruited and evaluated for the primary outcome per protocol design.
A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor
Outcome measures
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
n=27 Participants
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery
|
19 percentage of participants
Interval 6.0 to 38.0
|
SECONDARY outcome
Timeframe: Up to 55 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 1 participant was not evaluated for adverse events.
Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
n=81 Participants
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis
Pneumonitis
|
0 percentage of participants
|
|
Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis
Esophagitis
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 1 participant was not evaluated for adverse events.
Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0
Outcome measures
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
n=81 Participants
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity
|
72 percentage of participants
|
Adverse Events
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
Serious events: 6 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
n=81 participants at risk
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.2%
5/81 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.2%
1/81 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/81 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
2/81 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
3/81 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.9%
4/81 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
3/81 • Number of events 4
|
|
General disorders
Disease progression
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Edema limbs
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Fatigue
|
4.9%
4/81 • Number of events 5
|
|
General disorders
Pain
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Infectious colitis
|
1.2%
1/81 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
1.2%
1/81 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
1.2%
1/81 • Number of events 1
|
|
Investigations
Creatinine increased
|
1.2%
1/81 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
6.2%
5/81 • Number of events 5
|
|
Investigations
Lymphocyte count decreased
|
1.2%
1/81 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
4.9%
4/81 • Number of events 4
|
|
Investigations
Platelet count decreased
|
6.2%
5/81 • Number of events 6
|
|
Investigations
Weight loss
|
3.7%
3/81 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
3.7%
3/81 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
4.9%
4/81 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
3/81 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
2.5%
2/81 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.5%
2/81 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.2%
1/81 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
3.7%
3/81 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Tremor
|
1.2%
1/81 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.5%
2/81 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/81 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
2/81 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
2/81 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.2%
1/81 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.5%
2/81 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Chemoradiotherapy, Surgery)
n=81 participants at risk
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m\^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m\^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.9%
4/81 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
87.7%
71/81 • Number of events 190
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.5%
2/81 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/81 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
1.2%
1/81 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
2.5%
2/81 • Number of events 3
|
|
Cardiac disorders
Palpitations
|
1.2%
1/81 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
3.7%
3/81 • Number of events 3
|
|
Ear and labyrinth disorders
Ear disorder
|
2.5%
2/81 • Number of events 5
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.5%
2/81 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
9/81 • Number of events 20
|
|
Eye disorders
Dry eye syndrome
|
2.5%
2/81 • Number of events 2
|
|
Eye disorders
Eye disorder
|
1.2%
1/81 • Number of events 1
|
|
Eye disorders
Flashing vision
|
1.2%
1/81 • Number of events 2
|
|
Eye disorders
Vision blurred
|
3.7%
3/81 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
17.3%
14/81 • Number of events 19
|
|
Gastrointestinal disorders
Constipation
|
44.4%
36/81 • Number of events 65
|
|
Gastrointestinal disorders
Diarrhea
|
46.9%
38/81 • Number of events 65
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
7/81 • Number of events 10
|
|
Gastrointestinal disorders
Dysphagia
|
49.4%
40/81 • Number of events 87
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
7.4%
6/81 • Number of events 8
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.5%
2/81 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
16.0%
13/81 • Number of events 15
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/81 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.5%
2/81 • Number of events 2
|
|
Gastrointestinal disorders
Gingival pain
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.2%
1/81 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
22.2%
18/81 • Number of events 26
|
|
Gastrointestinal disorders
Nausea
|
65.4%
53/81 • Number of events 106
|
|
Gastrointestinal disorders
Oral pain
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.5%
2/81 • Number of events 3
|
|
Gastrointestinal disorders
Salivary gland disorder
|
1.2%
1/81 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
2.5%
2/81 • Number of events 2
|
|
Gastrointestinal disorders
Tooth development disorder
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
26/81 • Number of events 38
|
|
General disorders
Chest pain
|
6.2%
5/81 • Number of events 5
|
|
General disorders
Chills
|
2.5%
2/81 • Number of events 3
|
|
General disorders
Edema limbs
|
3.7%
3/81 • Number of events 3
|
|
General disorders
Fatigue
|
74.1%
60/81 • Number of events 158
|
|
General disorders
Fever
|
4.9%
4/81 • Number of events 4
|
|
General disorders
Hypothermia
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Pain
|
8.6%
7/81 • Number of events 9
|
|
Infections and infestations
Device related infection
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Infective myositis
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Paranasal sinus infection
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.5%
2/81 • Number of events 3
|
|
Infections and infestations
Upper respiratory infection
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Wound infection
|
1.2%
1/81 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
2.5%
2/81 • Number of events 3
|
|
Injury, poisoning and procedural complications
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
|
1.2%
1/81 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
6.2%
5/81 • Number of events 7
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.2%
1/81 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.2%
1/81 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
12.3%
10/81 • Number of events 16
|
|
Investigations
Alkaline phosphatase increased
|
12.3%
10/81 • Number of events 16
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
6/81 • Number of events 8
|
|
Investigations
Blood bilirubin increased
|
3.7%
3/81 • Number of events 3
|
|
Investigations
Coagulopathy
|
1.2%
1/81 • Number of events 1
|
|
Investigations
Creatinine increased
|
6.2%
5/81 • Number of events 7
|
|
Investigations
INR increased
|
1.2%
1/81 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
1.2%
1/81 • Number of events 3
|
|
Investigations
Leukocyte count decreased
|
86.4%
70/81 • Number of events 165
|
|
Investigations
Lymphocyte count decreased
|
28.4%
23/81 • Number of events 44
|
|
Investigations
Neutrophil count decreased
|
65.4%
53/81 • Number of events 112
|
|
Investigations
Platelet count decreased
|
59.3%
48/81 • Number of events 88
|
|
Investigations
Weight gain
|
2.5%
2/81 • Number of events 5
|
|
Investigations
Weight loss
|
22.2%
18/81 • Number of events 27
|
|
Metabolism and nutrition disorders
Anorexia
|
48.1%
39/81 • Number of events 67
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
45.7%
37/81 • Number of events 79
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
27/81 • Number of events 35
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
22.2%
18/81 • Number of events 32
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
18.5%
15/81 • Number of events 23
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
18.5%
15/81 • Number of events 24
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
3.7%
3/81 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
12.3%
10/81 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.9%
4/81 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
34.6%
28/81 • Number of events 40
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.2%
5/81 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
1.2%
1/81 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
4/81 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
7/81 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.7%
3/81 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.5%
2/81 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.2%
1/81 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
2/81 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/81 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/81 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
12.3%
10/81 • Number of events 16
|
|
Nervous system disorders
Dysgeusia
|
8.6%
7/81 • Number of events 13
|
|
Nervous system disorders
Headache
|
12.3%
10/81 • Number of events 12
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.5%
2/81 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.9%
21/81 • Number of events 48
|
|
Nervous system disorders
Syncope
|
3.7%
3/81 • Number of events 6
|
|
Nervous system disorders
Tremor
|
1.2%
1/81 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
6.2%
5/81 • Number of events 8
|
|
Psychiatric disorders
Confusion
|
3.7%
3/81 • Number of events 3
|
|
Psychiatric disorders
Depression
|
12.3%
10/81 • Number of events 15
|
|
Psychiatric disorders
Euphoria
|
1.2%
1/81 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
23.5%
19/81 • Number of events 38
|
|
Renal and urinary disorders
Bladder pain
|
1.2%
1/81 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
2.5%
2/81 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/81 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
3.7%
3/81 • Number of events 6
|
|
Renal and urinary disorders
Urogenital disorder
|
1.2%
1/81 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.5%
2/81 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.5%
2/81 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
11/81 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
18/81 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
2/81 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.9%
4/81 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.6%
7/81 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.5%
2/81 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.0%
30/81 • Number of events 61
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
7/81 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.2%
1/81 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
2/81 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
8.6%
7/81 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.5%
2/81 • Number of events 2
|
|
Vascular disorders
Hemorrhage
|
1.2%
1/81 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
1.2%
1/81 • Number of events 2
|
|
Vascular disorders
Hypertension
|
2.5%
2/81 • Number of events 4
|
|
Vascular disorders
Hypotension
|
7.4%
6/81 • Number of events 6
|
|
Vascular disorders
Phlebitis
|
1.2%
1/81 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
6.2%
5/81 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60