Trial Outcomes & Findings for Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer (NCT NCT00551070)
NCT ID: NCT00551070
Last Updated: 2020-12-03
Results Overview
Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Every other cycle
Results posted on
2020-12-03
Participant Flow
The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).
Participant milestones
| Measure |
AZD6244
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
Baseline characteristics by cohort
| Measure |
AZD6244
n=52 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Age, Customized
20-29 years
|
3 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
11 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
8 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
17 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
9 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other cyclePopulation: Eligible and treated patients
Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
Outcome measures
| Measure |
AZD6244
n=52 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Tumor Response
|
15.4 percentage of patients
Interval 7.9 to 26.1
|
PRIMARY outcome
Timeframe: Cycle 1Population: Eligible and treated patients.
Outcome measures
| Measure |
AZD6244
n=52 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Coagulation
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Leukopenia
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Thrombocytopenia
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Neutropenia
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Anemia
|
2 percentage of patients
Interval 0.0 to 10.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Allergy/Immunology
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Auditory/Ear
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Cardiac
|
2 percentage of patients
Interval 0.0 to 10.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Constitutional
|
4 percentage of patients
Interval 0.0 to 13.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Dermatologic
|
12 percentage of patients
Interval 4.0 to 23.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Gastrointestinal
|
13 percentage of patients
Interval 6.0 to 26.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Genitourinary/Renal
|
2 percentage of patients
Interval 0.0 to 10.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Hemorrhage
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Infection
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Lymphatics
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Metabolic
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Musculoskeletal
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Neurosensory
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Other Neurological
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Ocular/Visual
|
0 percentage of patients
Interval 0.0 to 7.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Pain
|
4 percentage of patients
Interval 0.0 to 13.0
|
|
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Pulmonary
|
4 percentage of patients
Interval 0.0 to 13.0
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatmentPopulation: Eligible and Treated Patients with all pharmacokinetic time points available
Outcome measures
| Measure |
AZD6244
n=41 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.
|
2419 ng x hr/mL
Interval 1673.0 to 3186.0
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatmentPopulation: Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available
Outcome measures
| Measure |
AZD6244
n=42 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.
|
585 ng/mL
Interval 371.0 to 1100.0
|
SECONDARY outcome
Timeframe: Every other cyclePopulation: Eligible and Treated Patients
Outcome measures
| Measure |
AZD6244
n=52 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Progression-free Survival
|
11.3 months
Interval 6.2 to 12.9
|
SECONDARY outcome
Timeframe: Every cyclePopulation: Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.
Outcome measures
| Measure |
AZD6244
n=52 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Number of Courses Received
|
5 courses
Interval 2.0 to 14.0
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 yearsPopulation: Eligible and Treated Patients
Outcome measures
| Measure |
AZD6244
n=52 Participants
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Overall Survival
|
32.4 Months
Interval 17.7 to 39.3
|
Adverse Events
AZD6244
Serious events: 33 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD6244
n=52 participants at risk
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
Prolonged Qtc Interval
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
Hypertension
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
Hypotension
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Weight Gain
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Ulcer,gi - Esophagus
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Dehydration
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Stricture, Gi - Biliary Tree
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Alt
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Mood Alteration - Depression
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Back
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Abdominal Pain Nos
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Ards
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
Other adverse events
| Measure |
AZD6244
n=52 participants at risk
AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Immune system disorders
Rhinitis
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Neutrophils
|
19.2%
10/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Platelets
|
11.5%
6/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Leukocytes
|
21.2%
11/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
53.8%
28/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
Prolonged Qtc Interval
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
Palpitations
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Cardiac disorders
Hypertension
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Inr
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Constitutional Symptoms - Other
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Sweating
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Weight Gain
|
21.2%
11/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Fever
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Weight Loss
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Rigors/Chills
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Fatigue
|
75.0%
39/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Insomnia
|
11.5%
6/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
19.2%
10/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Acne
|
17.3%
9/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Rash
|
59.6%
31/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
17.3%
9/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Endocrine disorders
Hot Flashes
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Gastritis
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Heartburn
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Distention
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Taste Alteration
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
17.3%
9/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Esophagus
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Vomiting
|
48.1%
25/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Anorexia
|
23.1%
12/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Dehydration
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
16/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Nausea
|
67.3%
35/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
78.8%
41/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Bronchopulmonary Nos
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Infection - Other
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf Unknown Anc: Pharynx
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Lymphocele
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
46.2%
24/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Ast
|
46.2%
24/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Proteinuria
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Creatinine
|
15.4%
8/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.1%
12/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Ggt
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Alt
|
38.5%
20/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
30.8%
16/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.5%
7/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.3%
9/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
12/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
34.6%
18/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Neurology - Other
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Mood Alteration - Depression
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
17.3%
9/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Tremor
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Speech Impairment
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Cognitive Disturbance
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Memory Impairment
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Dizziness
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Nervous system disorders
Neuropathy-Sensory
|
38.5%
20/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Eye disorders
Ocular/Visual - Other
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Eye disorders
Watery Eye
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Eye disorders
Dry Eye
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Eye disorders
Blurred Vision
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain - Other
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Urethra
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Chest /Thorax Nos
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
5.8%
3/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Head/Headache
|
17.3%
9/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Neck
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Intestine
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Extremity-Limb
|
15.4%
8/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Back
|
13.5%
7/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Joint
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Bladder
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Pain Nos
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Abdominal Pain Nos
|
38.5%
20/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Skin
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Cardiac/ Heart
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Muscle
|
9.6%
5/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Anus
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
General disorders
Pain: Sinus
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
4/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.8%
16/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Renal and urinary disorders
Urinary Frequency
|
3.8%
2/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.9%
1/52 • Study Treatment
Includes all adverse events reported (grade 1-5) regardless of attribution.
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60