Trial Outcomes & Findings for Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery (NCT NCT00553462)
NCT ID: NCT00553462
Last Updated: 2018-01-31
Results Overview
Percentage of participants who were alive at 12 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
At 12 months
Results posted on
2018-01-31
Participant Flow
Between March 2008 and October 2011, 78 participants were recruited to this study.
Three participants did not receive any protocol treatment and were excluded from all analyses.
Participant milestones
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Progression
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
n=75 Participants
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Age, Continuous
|
68 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At 12 monthsPercentage of participants who were alive at 12 months.
Outcome measures
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
n=75 Participants
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Overall Survival at 12 Months
|
57 percentage of participants
Interval 47.0 to 70.0
|
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; * Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; * Stable Disease (SD): small changes that do not meet above criteria. Response rate is reported as the percentage of participants who achieved each response.
Outcome measures
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
n=75 Participants
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Response Rate
Complete Response (CR)
|
8 percentage of participants
|
|
Response Rate
Partial Response (PR)
|
59 percentage of participants
|
|
Response Rate
Stable Disease (SD)
|
27 percentage of participants
|
|
Response Rate
Progressive Disease (PD)
|
7 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of study (up to 2 years)Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
n=75 Participants
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Progression-free Survival
|
11 months
Interval 9.0 to 16.0
|
Adverse Events
Paclitaxel + Carboplatin + Radiation + Erlotinib
Serious events: 19 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
n=75 participants at risk
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
1.3%
1/75 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.3%
1/75 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
18.7%
14/75 • Number of events 15
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.3%
1/75 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
3/75 • Number of events 4
|
|
Cardiac disorders
Atrial flutter
|
1.3%
1/75 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
4.0%
3/75 • Number of events 4
|
|
Cardiac disorders
Cardiac pain
|
2.7%
2/75 • Number of events 2
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.3%
1/75 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
2.7%
2/75 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
1/75 • Number of events 1
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.3%
1/75 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/75 • Number of events 1
|
|
Eye disorders
Vision blurred
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.3%
7/75 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
8/75 • Number of events 8
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
5/75 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
6/75 • Number of events 6
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.7%
2/75 • Number of events 2
|
|
Gastrointestinal disorders
Esophageal mucositis
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
6.7%
5/75 • Number of events 5
|
|
Gastrointestinal disorders
Ileal hemorrhage
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
13.3%
10/75 • Number of events 13
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
4/75 • Number of events 5
|
|
General disorders
Chest pain
|
5.3%
4/75 • Number of events 4
|
|
General disorders
Chills
|
1.3%
1/75 • Number of events 2
|
|
General disorders
Edema limbs
|
2.7%
2/75 • Number of events 2
|
|
General disorders
Fatigue
|
20.0%
15/75 • Number of events 20
|
|
General disorders
Fever
|
2.7%
2/75 • Number of events 2
|
|
General disorders
General symptom
|
1.3%
1/75 • Number of events 1
|
|
General disorders
Pain
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Esophageal infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Hepatic infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Infection
|
2.7%
2/75 • Number of events 3
|
|
Infections and infestations
Opportunistic infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.7%
2/75 • Number of events 3
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
1.3%
1/75 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.7%
2/75 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
4/75 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
3/75 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
4.0%
3/75 • Number of events 3
|
|
Investigations
Coagulopathy
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Creatinine increased
|
9.3%
7/75 • Number of events 7
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
1.3%
1/75 • Number of events 1
|
|
Investigations
INR increased
|
2.7%
2/75 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
16.0%
12/75 • Number of events 12
|
|
Investigations
Lymphocyte count decreased
|
10.7%
8/75 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
8.0%
6/75 • Number of events 6
|
|
Investigations
Platelet count decreased
|
14.7%
11/75 • Number of events 12
|
|
Investigations
Weight loss
|
9.3%
7/75 • Number of events 7
|
|
Metabolism and nutrition disorders
Anorexia
|
14.7%
11/75 • Number of events 12
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
17.3%
13/75 • Number of events 14
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
1.3%
1/75 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
7/75 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
9.3%
7/75 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
10.7%
8/75 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
5.3%
4/75 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
4.0%
3/75 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.7%
2/75 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.7%
2/75 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
9.3%
7/75 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.3%
4/75 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.0%
3/75 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.3%
1/75 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
3/75 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/75 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.0%
3/75 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.0%
3/75 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
1.3%
1/75 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
4.0%
3/75 • Number of events 4
|
|
Nervous system disorders
Headache
|
5.3%
4/75 • Number of events 4
|
|
Nervous system disorders
Ischemia cerebrovascular
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Mini mental status examination abnormal
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
4/75 • Number of events 4
|
|
Nervous system disorders
Tremor
|
1.3%
1/75 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
2.7%
2/75 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
4.0%
3/75 • Number of events 3
|
|
Psychiatric disorders
Confusion
|
2.7%
2/75 • Number of events 3
|
|
Psychiatric disorders
Depression
|
5.3%
4/75 • Number of events 4
|
|
Psychiatric disorders
Personality change
|
1.3%
1/75 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
1.3%
1/75 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
5/75 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
8/75 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
15/75 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
4/75 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
2/75 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.3%
4/75 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.3%
1/75 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.7%
2/75 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
3/75 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/75 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
12.0%
9/75 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.3%
1/75 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
2.7%
2/75 • Number of events 2
|
|
Vascular disorders
Hypertension
|
2.7%
2/75 • Number of events 3
|
|
Vascular disorders
Hypotension
|
4.0%
3/75 • Number of events 3
|
Other adverse events
| Measure |
Paclitaxel + Carboplatin + Radiation + Erlotinib
n=75 participants at risk
Patients receive paclitaxel 100 mg/m\^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
64.0%
48/75 • Number of events 98
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.7%
2/75 • Number of events 3
|
|
Blood and lymphatic system disorders
Spleen disorder
|
1.3%
1/75 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
1.3%
1/75 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
2/75 • Number of events 3
|
|
Cardiac disorders
Palpitations
|
1.3%
1/75 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
4/75 • Number of events 6
|
|
Ear and labyrinth disorders
Ear pain
|
2.7%
2/75 • Number of events 3
|
|
Ear and labyrinth disorders
External ear pain
|
1.3%
1/75 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
1/75 • Number of events 3
|
|
Endocrine disorders
Cushingoid
|
1.3%
1/75 • Number of events 2
|
|
Eye disorders
Cataract
|
1.3%
1/75 • Number of events 3
|
|
Eye disorders
Conjunctivitis
|
1.3%
1/75 • Number of events 1
|
|
Eye disorders
Diplopia
|
1.3%
1/75 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
1.3%
1/75 • Number of events 3
|
|
Eye disorders
Eye disorder
|
1.3%
1/75 • Number of events 1
|
|
Eye disorders
Eye pain
|
1.3%
1/75 • Number of events 1
|
|
Eye disorders
Flashing vision
|
1.3%
1/75 • Number of events 3
|
|
Eye disorders
Vision blurred
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
9/75 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
26.7%
20/75 • Number of events 28
|
|
Gastrointestinal disorders
Diarrhea
|
36.0%
27/75 • Number of events 40
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
3/75 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
3/75 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
16.0%
12/75 • Number of events 13
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
17.3%
13/75 • Number of events 13
|
|
Gastrointestinal disorders
Esophageal pain
|
6.7%
5/75 • Number of events 5
|
|
Gastrointestinal disorders
Esophagitis
|
21.3%
16/75 • Number of events 16
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.7%
2/75 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
1/75 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.0%
3/75 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
48.0%
36/75 • Number of events 52
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
29.3%
22/75 • Number of events 25
|
|
General disorders
Chest pain
|
4.0%
3/75 • Number of events 5
|
|
General disorders
Chills
|
4.0%
3/75 • Number of events 3
|
|
General disorders
Edema limbs
|
9.3%
7/75 • Number of events 8
|
|
General disorders
Facial pain
|
1.3%
1/75 • Number of events 1
|
|
General disorders
Fatigue
|
86.7%
65/75 • Number of events 126
|
|
General disorders
Fever
|
6.7%
5/75 • Number of events 5
|
|
General disorders
Gait abnormal
|
1.3%
1/75 • Number of events 1
|
|
General disorders
General symptom
|
1.3%
1/75 • Number of events 1
|
|
General disorders
Injection site reaction
|
1.3%
1/75 • Number of events 1
|
|
General disorders
Pain
|
6.7%
5/75 • Number of events 6
|
|
General disorders
Visceral edema
|
1.3%
1/75 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.7%
2/75 • Number of events 2
|
|
Infections and infestations
Catheter related infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Esophageal infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Lip infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
5.3%
4/75 • Number of events 6
|
|
Infections and infestations
Sinusitis
|
2.7%
2/75 • Number of events 2
|
|
Infections and infestations
Skin infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
Vaginal infection
|
1.3%
1/75 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
1.3%
1/75 • Number of events 2
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
4.0%
3/75 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/75 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
5.3%
4/75 • Number of events 4
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.0%
3/75 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
9/75 • Number of events 9
|
|
Investigations
Alkaline phosphatase
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
9/75 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
12/75 • Number of events 17
|
|
Investigations
Blood bilirubin increased
|
6.7%
5/75 • Number of events 5
|
|
Investigations
Creatinine increased
|
10.7%
8/75 • Number of events 12
|
|
Investigations
INR increased
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
37.3%
28/75 • Number of events 43
|
|
Investigations
Lymphocyte count decreased
|
33.3%
25/75 • Number of events 34
|
|
Investigations
Neutrophil count decreased
|
42.7%
32/75 • Number of events 48
|
|
Investigations
Platelet count decreased
|
34.7%
26/75 • Number of events 44
|
|
Investigations
Weight gain
|
1.3%
1/75 • Number of events 1
|
|
Investigations
Weight loss
|
22.7%
17/75 • Number of events 21
|
|
Metabolism and nutrition disorders
Anorexia
|
24.0%
18/75 • Number of events 31
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.3%
1/75 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
44.0%
33/75 • Number of events 44
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
10/75 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
24.0%
18/75 • Number of events 29
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
8.0%
6/75 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.3%
1/75 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
12.0%
9/75 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
10.7%
8/75 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
5.3%
4/75 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
20.0%
15/75 • Number of events 18
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.7%
5/75 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
22.7%
17/75 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
5/75 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.7%
2/75 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
8/75 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/75 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.3%
7/75 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.0%
6/75 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.3%
1/75 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.3%
1/75 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
3/75 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
6/75 • Number of events 8
|
|
Nervous system disorders
Ataxia
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.0%
9/75 • Number of events 18
|
|
Nervous system disorders
Dysgeusia
|
10.7%
8/75 • Number of events 11
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.3%
1/75 • Number of events 2
|
|
Nervous system disorders
Headache
|
9.3%
7/75 • Number of events 14
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.7%
2/75 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.7%
20/75 • Number of events 34
|
|
Nervous system disorders
Seizure
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
Tremor
|
4.0%
3/75 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
8.0%
6/75 • Number of events 11
|
|
Psychiatric disorders
Confusion
|
2.7%
2/75 • Number of events 2
|
|
Psychiatric disorders
Depression
|
9.3%
7/75 • Number of events 10
|
|
Psychiatric disorders
Euphoria
|
1.3%
1/75 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
16.0%
12/75 • Number of events 17
|
|
Renal and urinary disorders
Bladder pain
|
1.3%
1/75 • Number of events 1
|
|
Renal and urinary disorders
Kidney pain
|
1.3%
1/75 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
1.3%
1/75 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
2.7%
2/75 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
1.3%
1/75 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
8.0%
6/75 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.7%
26/75 • Number of events 44
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
64.0%
48/75 • Number of events 88
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
6/75 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.0%
3/75 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.7%
2/75 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.3%
1/75 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
1.3%
1/75 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.7%
5/75 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
2.7%
2/75 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.3%
4/75 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.7%
23/75 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
4/75 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.3%
1/75 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.3%
1/75 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
9/75 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
5/75 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
45.3%
34/75 • Number of events 38
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.3%
1/75 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
5.3%
4/75 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.3%
1/75 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
1/75 • Number of events 2
|
|
Vascular disorders
Flushing
|
2.7%
2/75 • Number of events 4
|
|
Vascular disorders
Hemorrhage
|
1.3%
1/75 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
4.0%
3/75 • Number of events 5
|
|
Vascular disorders
Hypertension
|
4.0%
3/75 • Number of events 5
|
|
Vascular disorders
Hypotension
|
4.0%
3/75 • Number of events 4
|
|
Vascular disorders
Vascular disorder
|
1.3%
1/75 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60