Trial Outcomes & Findings for LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer (NCT NCT02328105)
NCT ID: NCT02328105
Last Updated: 2022-08-09
Results Overview
The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by \>= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to a planned 18 weeks
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
Carboplatin + Abraxane
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Carboplatin + Abraxane
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Still On Study in Follow-Up
|
4
|
Baseline Characteristics
LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin + Abraxane
n=11 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
66.09 years
STANDARD_DEVIATION 8.95 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
|
ECOG at Baseline
ECOG 0
|
5 Participants
n=99 Participants
|
|
ECOG at Baseline
ECOG 1
|
6 Participants
n=99 Participants
|
|
Primary Tumor Site - Lung
|
11 Participants
n=99 Participants
|
|
Tumor Histology - Squamous NSCLC
|
11 Participants
n=99 Participants
|
|
Stage - IV
|
11 Participants
n=99 Participants
|
|
Tumor Grade
High
|
7 Participants
n=99 Participants
|
|
Tumor Grade
Low
|
4 Participants
n=99 Participants
|
|
Smoking Status
Previous Smoker
|
7 Participants
n=99 Participants
|
|
Smoking Status
Current Smoker
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to a planned 18 weeksPopulation: The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically)
The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by \>= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.
Outcome measures
| Measure |
Carboplatin + Abraxane
n=11 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Number of Participants With a Response
|
4 Participants
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically).
Disease control is calculated for each subject indicating whether or not they achieved an overall response of stable disease or better by RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions, a PR is indicated by \>= 30% decrease in sum of longest diameter of target lesions with baseline as reference, and SD is neither sufficient shrinkage to qualify for PR nor sufficient growth, \>=20%, to indicate progression).
Outcome measures
| Measure |
Carboplatin + Abraxane
n=11 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Number of Subjects With Stable Disease or Response
|
9 Participants
|
SECONDARY outcome
Timeframe: From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 3 yearsPopulation: Efficacy analyses were conducted on the population of subjects who began Carboplatin + Abraxane treatment
PFS is defined as time from enrollment to time of progression or death. Disease progression (PD) may be determined objectively per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of longest diameters of target lesions, a measurable increase in non-target lesion, or appearance of new lesions) or subjectively as determined by investigator (with evidence documented in the medical records). If the subject died without documented PD, date of progression will be date of death. For surviving subjects who did not have documented PD, PFS was censored at last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experienced a PFS event following an interval equal to two or more scheduled radiologic assessments were censored at last assessment prior to first missed assessment.
Outcome measures
| Measure |
Carboplatin + Abraxane
n=11 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Progression Free Survival
|
7.3 months
Interval 2.2 to 13.0
|
SECONDARY outcome
Timeframe: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 yearsPopulation: Efficacy analyses were conducted on the population of subjects who began Carboplatin + Abraxane treatment
OS is defined as the duration of time from enrollment to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.
Outcome measures
| Measure |
Carboplatin + Abraxane
n=11 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Overall Survival
|
30 months
Interval 2.2 to
Upper limit of the confidence interval is not reached due to censoring rate.
|
SECONDARY outcome
Timeframe: From date of response to date of progression/death, or censored as described above; assessed for approximately 3 years.Population: Efficacy analyses were conducted on the population of subjects who began Carboplatin + Abraxane treatment. Duration of response was conducted specifically on those subjects in the efficacy population who achieved objective response (PR or CR).
For subjects who achieve a CR or PR, response duration will be measured from the first day of the response until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.
Outcome measures
| Measure |
Carboplatin + Abraxane
n=4 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Duration of Response
|
10.8 months
Interval 4.9 to 11.9
|
SECONDARY outcome
Timeframe: From date of treatment start to date of progression, or censored as described above; assessed for approximately 3 yearsPopulation: Efficacy analyses were conducted on the population of subjects who began Carboplatin + Abraxane treatment. Duration of disease control was conducted specifically on those subjects in the efficacy population who achieved disease control (stable disease or better).
For subjects who achieve SD or better, duration of disease control will be measured from the treatment start date until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.
Outcome measures
| Measure |
Carboplatin + Abraxane
n=9 Participants
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Duration of Disease Control
|
7.3 months
Interval 3.0 to 13.0
|
Adverse Events
Carboplatin + Abraxane
Serious events: 2 serious events
Other events: 11 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Carboplatin + Abraxane
n=11 participants at risk
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
White blood cell decreased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Fatigue
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
Other adverse events
| Measure |
Carboplatin + Abraxane
n=11 participants at risk
Carboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m\^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
90.9%
10/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Fatigue
|
81.8%
9/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Platelet count decreased
|
72.7%
8/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
63.6%
7/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
54.5%
6/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Neutrophil count decreased
|
54.5%
6/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hyponatremia
|
45.5%
5/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Edema limbs
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Mucositis oral
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
36.4%
4/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Alkaline phosphatase increased
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Weight loss
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Vascular disorders
Hypotension
|
27.3%
3/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
White blood cell decreased
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Skin infection
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Urinary tract infection
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Lung infection
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Chills
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Localized edema
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Cardiac disorders
Sinus tachycardia
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Nervous system disorders
Dysgeusia
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Gum infection
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Infections and infestations
Mucosal infection
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Fever
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Infusion related reaction
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Neck edema
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Oral hemorrhage
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Stomach pain
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Eye disorders
Conjunctivitis
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Vascular disorders
Hot flashes
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Nervous system disorders
Neuralgia
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Renal and urinary disorders
Urinary frequency
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Renal and urinary disorders
Urinary incontinence
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Renal and urinary disorders
Urinary tract obstruction
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Renal and urinary disorders
Cystitis noninfective
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
9.1%
1/11 • Baseline, during treatment (up to a planned 18 weeks), and 30 days after last dose of treatment administration
|
Additional Information
Chair of Biostatistics Department
Levine Cancer Institute
Phone: 9804422371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place