Trial Outcomes & Findings for Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC (NCT NCT00280735)
NCT ID: NCT00280735
Last Updated: 2017-07-11
Results Overview
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
12 weeks from initiating adjuvant therapy
Results posted on
2017-07-11
Participant Flow
Of the 75 participants screened for eligibility, 72 went on to treatment and 3 participants withdrew consent prior to treatment.
Participant milestones
| Measure |
Single Arm Trial
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
Received Treatment
|
72
|
|
Overall Study
Received Adequate Exposure
|
57
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Single Arm Trial
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Intercurrent Illness
|
2
|
Baseline Characteristics
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Baseline characteristics by cohort
| Measure |
Single Arm Trial
n=72 Participants
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
60 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African American
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Latino
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
0
|
28 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
1
|
43 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
2
|
1 Participants
n=99 Participants
|
|
Stage
Stage I
|
29 Participants
n=99 Participants
|
|
Stage
Stage II
|
26 Participants
n=99 Participants
|
|
Stage
Stage IIIA
|
16 Participants
n=99 Participants
|
|
Stage
Stage IIIB
|
1 Participants
n=99 Participants
|
|
Histology
Adenocarcinoma
|
32 Participants
n=99 Participants
|
|
Histology
Squamous cell carcinoma
|
30 Participants
n=99 Participants
|
|
Histology
Non-small cell-not otherwise specified
|
7 Participants
n=99 Participants
|
|
Histology
Large cell carcinoma
|
3 Participants
n=99 Participants
|
|
Type of surgery
Wedge resection
|
2 Participants
n=99 Participants
|
|
Type of surgery
Lobectomy
|
52 Participants
n=99 Participants
|
|
Type of surgery
Bi-lobectomy
|
7 Participants
n=99 Participants
|
|
Type of surgery
Pneumonectomy
|
11 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from initiating adjuvant therapyPopulation: Patients assigned to treatment
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
Outcome measures
| Measure |
Single Arm Trial
n=72 Participants
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
Grade 4 %
Percentage of patients receiving treatment who developed this toxicity
|
Grade 3/4 %
Percentage of patients receiving treatment who developed this toxicity
|
|---|---|---|---|
|
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
|
57 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPatterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.
Outcome measures
| Measure |
Single Arm Trial
n=19 Participants
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
Grade 4 %
Percentage of patients receiving treatment who developed this toxicity
|
Grade 3/4 %
Percentage of patients receiving treatment who developed this toxicity
|
|---|---|---|---|
|
Patterns of Recurrence in Patients Treated With This Regimen
intrathoracic relapse
|
4 Participants
|
—
|
—
|
|
Patterns of Recurrence in Patients Treated With This Regimen
intrathoracic and distant relapse
|
5 Participants
|
—
|
—
|
|
Patterns of Recurrence in Patients Treated With This Regimen
distant relapse only without brain
|
2 Participants
|
—
|
—
|
|
Patterns of Recurrence in Patients Treated With This Regimen
distant relapse within the brain
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of treatment to 30 days after treatment discontinuationPopulation: Patients receiving treatment
Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
Outcome measures
| Measure |
Single Arm Trial
n=72 Participants
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
Grade 4 %
n=72 Participants
Percentage of patients receiving treatment who developed this toxicity
|
Grade 3/4 %
n=72 Participants
Percentage of patients receiving treatment who developed this toxicity
|
|---|---|---|---|
|
Toxicity in Patients Treated With This Regimen
Neutropenia
|
24 percentage of participants
|
42 percentage of participants
|
65 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Fatigue/asthenia
|
5.5 percentage of participants
|
0 percentage of participants
|
5.5 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Thrombocytopenia
|
1 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Febrile Neutorpenia
|
3 percentage of participants
|
8 percentage of participants
|
11 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Nausea
|
1 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Vomiting
|
1 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Diarrhea
|
3 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Infusional reactions
|
4 percentage of participants
|
0 percentage of participants
|
4 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Dehydration
|
1 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Syncope
|
5.5 percentage of participants
|
0 percentage of participants
|
5.5 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Arrythmia
|
0 percentage of participants
|
1 percentage of participants
|
1 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Proteinuria
|
0 percentage of participants
|
1 percentage of participants
|
1 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Infection
|
0 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
|
Toxicity in Patients Treated With This Regimen
Dyspnea
|
0 percentage of participants
|
1 percentage of participants
|
1 percentage of participants
|
SECONDARY outcome
Timeframe: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 monthsPopulation: Participants receiving treatment
Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.
Outcome measures
| Measure |
Single Arm Trial
n=72 Participants
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
Grade 4 %
Percentage of patients receiving treatment who developed this toxicity
|
Grade 3/4 %
Percentage of patients receiving treatment who developed this toxicity
|
|---|---|---|---|
|
Progression Free Survival
|
86 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 monthsPopulation: Participants receiving treatment
Overall survival rate at 18 months.
Outcome measures
| Measure |
Single Arm Trial
n=72 Participants
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
Grade 4 %
Percentage of patients receiving treatment who developed this toxicity
|
Grade 3/4 %
Percentage of patients receiving treatment who developed this toxicity
|
|---|---|---|---|
|
Overall Survival
|
86 percentage of participants
|
—
|
—
|
Adverse Events
Single Arm Trial
Serious events: 19 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Trial
n=72 participants at risk
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.8%
2/72 • Number of events 2 • 30 days following cessation of treatment
|
|
Vascular disorders
Hypotension
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Supraventricular arrhythmia not otherwise specified (NOS)
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/72 • Number of events 2 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
3/72 • Number of events 3 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • Number of events 2 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • Number of events 2 • 30 days following cessation of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
8/72 • Number of events 9 • 30 days following cessation of treatment
|
|
Infections and infestations
Infections, Other (Specify, _Neutropenic sepsis)
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
|
Nervous system disorders
Syncope (fainting)
|
2.8%
2/72 • Number of events 3 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
8.3%
6/72 • Number of events 8 • 30 days following cessation of treatment
|
|
Investigations
Leukocytes (total WBC)
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
1.4%
1/72 • Number of events 1 • 30 days following cessation of treatment
|
Other adverse events
| Measure |
Single Arm Trial
n=72 participants at risk
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
8.3%
6/72 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.6%
4/72 • 30 days following cessation of treatment
|
|
Investigations
Leukocytes (total WBC)
|
5.6%
4/72 • 30 days following cessation of treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
58.3%
42/72 • 30 days following cessation of treatment
|
|
Investigations
Platelets
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
General disorders
Constitutional Symptoms - Other (Specify- Weakness)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.8%
15/72 • 30 days following cessation of treatment
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Vascular disorders
Flushing
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.0%
18/72 • 30 days following cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
4/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
9/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.9%
5/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Nausea
|
18.1%
13/72 • 30 days following cessation of treatment
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
5.6%
4/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Ulcer, GI - Stomach
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
General disorders
Edema: limb
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Renal and urinary disorders
Proteinuria
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Nervous system disorders
Dizziness
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Nervous system disorders
Neuropathy: motor
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Nervous system disorders
Neuropathy: sensory
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
Nervous system disorders
Syncope (fainting)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Eye disorders
Dry eye syndrome
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - bone
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
General disorders
Pain -Chest
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
4.2%
3/72 • 30 days following cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
5.6%
4/72 • 30 days following cessation of treatment
|
|
General disorders
Pain - Other (Specify, _Thoracotomy site)
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
4/72 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.9%
5/72 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, _paranasal sinus reaction; runny nose/chills)
|
2.8%
2/72 • 30 days following cessation of treatment
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __UTI)
|
1.4%
1/72 • 30 days following cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
1.4%
1/72 • 30 days following cessation of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60