Trial Outcomes & Findings for Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571 (NCT NCT02127372)
NCT ID: NCT02127372
Last Updated: 2014-09-15
Results Overview
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
After cycle 1, day 22
Results posted on
2014-09-15
Participant Flow
Patients with Advanced Non-Small Cell Lung Cancer were enrolled from November 2004 to April 2009. The study was closed due to poor accrual.
Overall, 72 subject signed a consent form and 43 went on to start treatment on study. Of the 24 subjects who signed a consent form for Phase 1, 9 were screen failures and did not start study treatment. Of the 48 subjects who signed a consent form for Phase 2, 20 were screen failures and did not start study treatment.
Participant milestones
| Measure |
Phase 1
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
28
|
|
Overall Study
Started Study Treatment
|
15
|
28
|
|
Overall Study
COMPLETED
|
14
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 1
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571
Baseline characteristics by cohort
| Measure |
Phase 1
n=15 Participants
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
n=28 Participants
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
28 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After cycle 1, day 22Population: One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Outcome measures
| Measure |
Phase 1
n=14 Participants
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Phase 1 - Maximum Tolerated Dose (MTD) of STI571
|
400 mg
|
—
|
PRIMARY outcome
Timeframe: After cycle 1, day 22Population: One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Outcome measures
| Measure |
Phase 1
n=14 Participants
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
Docetaxel
|
60 mg/m2
|
—
|
|
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
Cisplatin
|
60 mg/m2
|
—
|
PRIMARY outcome
Timeframe: After Cycle 6, approximately 18 weeks.The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Phase II - Radiographic Response
|
25 percentage of participants
Interval 11.0 to 45.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearPhase II: Percentage of patients alive 1 year from the start of protocol treatment.
Outcome measures
| Measure |
Phase 1
n=28 Participants
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Phase 2: 1 Year Survival
|
61 percentage of participants
Interval 40.0 to 76.0
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Because the study was terminated prior to completion, correlative studies were not run.
The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Phase 2
Serious events: 15 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1
n=15 participants at risk
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
n=28 participants at risk
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.3%
2/15
|
7.1%
2/28
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15
|
7.1%
2/28
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15
|
3.6%
1/28
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15
|
7.1%
2/28
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15
|
3.6%
1/28
|
|
General disorders
Edema face
|
6.7%
1/15
|
0.00%
0/28
|
|
General disorders
Fever
|
6.7%
1/15
|
0.00%
0/28
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/15
|
3.6%
1/28
|
|
Infections and infestations
Lung infection
|
6.7%
1/15
|
10.7%
3/28
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/15
|
3.6%
1/28
|
|
Investigations
Creatinine increased
|
6.7%
1/15
|
0.00%
0/28
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15
|
14.3%
4/28
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/15
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/15
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15
|
3.6%
1/28
|
|
Psychiatric disorders
Confusion
|
0.00%
0/15
|
3.6%
1/28
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
6.7%
1/15
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15
|
0.00%
0/28
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15
|
17.9%
5/28
|
Other adverse events
| Measure |
Phase 1
n=15 participants at risk
Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
|
Phase 2
n=28 participants at risk
The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
46.7%
7/15
|
60.7%
17/28
|
|
Cardiac disorders
Myocardial infarction
|
6.7%
1/15
|
0.00%
0/28
|
|
Cardiac disorders
Ventricular tachycardia
|
6.7%
1/15
|
0.00%
0/28
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.7%
1/15
|
3.6%
1/28
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15
|
7.1%
2/28
|
|
Eye disorders
Blurred vision
|
6.7%
1/15
|
14.3%
4/28
|
|
Eye disorders
Dry eye
|
0.00%
0/15
|
3.6%
1/28
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/15
|
7.1%
2/28
|
|
Eye disorders
Flashing lights
|
6.7%
1/15
|
3.6%
1/28
|
|
Eye disorders
Watering eyes
|
13.3%
2/15
|
14.3%
4/28
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Gastrointestinal disorders
Cheilitis
|
13.3%
2/15
|
0.00%
0/28
|
|
Gastrointestinal disorders
Constipation
|
53.3%
8/15
|
21.4%
6/28
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
6/15
|
35.7%
10/28
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
3/15
|
17.9%
5/28
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/15
|
3.6%
1/28
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
6/15
|
25.0%
7/28
|
|
Gastrointestinal disorders
Nausea
|
86.7%
13/15
|
46.4%
13/28
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
6/15
|
28.6%
8/28
|
|
General disorders
Chills
|
6.7%
1/15
|
3.6%
1/28
|
|
General disorders
Edema face
|
20.0%
3/15
|
7.1%
2/28
|
|
General disorders
Edema limbs
|
33.3%
5/15
|
35.7%
10/28
|
|
General disorders
Edema trunk
|
6.7%
1/15
|
3.6%
1/28
|
|
General disorders
Fatigue
|
73.3%
11/15
|
64.3%
18/28
|
|
General disorders
Fever
|
20.0%
3/15
|
3.6%
1/28
|
|
General disorders
Non-cardiac chest pain
|
13.3%
2/15
|
10.7%
3/28
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/15
|
7.1%
2/28
|
|
Infections and infestations
Gum infection
|
6.7%
1/15
|
0.00%
0/28
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.7%
1/15
|
0.00%
0/28
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15
|
0.00%
0/28
|
|
Infections and infestations
Tooth infection
|
0.00%
0/15
|
3.6%
1/28
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15
|
7.1%
2/28
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15
|
3.6%
1/28
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15
|
7.1%
2/28
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/15
|
28.6%
8/28
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15
|
7.1%
2/28
|
|
Investigations
Creatinine increased
|
6.7%
1/15
|
10.7%
3/28
|
|
Investigations
Neutrophil count decreased
|
26.7%
4/15
|
21.4%
6/28
|
|
Investigations
Platelet count decreased
|
6.7%
1/15
|
14.3%
4/28
|
|
Investigations
Weight gain
|
6.7%
1/15
|
0.00%
0/28
|
|
Investigations
Weight loss
|
0.00%
0/15
|
3.6%
1/28
|
|
Investigations
White blood cell decreased
|
26.7%
4/15
|
21.4%
6/28
|
|
Metabolism and nutrition disorders
Anorexia
|
73.3%
11/15
|
50.0%
14/28
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
2/15
|
42.9%
12/28
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/15
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
2/15
|
50.0%
14/28
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
2/15
|
21.4%
6/28
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/15
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
3/15
|
14.3%
4/28
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.7%
4/15
|
25.0%
7/28
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15
|
25.0%
7/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15
|
10.7%
3/28
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
3/15
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
20.0%
3/15
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/15
|
10.7%
3/28
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/15
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
13.3%
2/15
|
10.7%
3/28
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.7%
1/15
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15
|
10.7%
3/28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15
|
10.7%
3/28
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15
|
0.00%
0/28
|
|
Nervous system disorders
Dysgeusia
|
46.7%
7/15
|
53.6%
15/28
|
|
Nervous system disorders
Extrapyramidal disorder
|
6.7%
1/15
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
20.0%
3/15
|
7.1%
2/28
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
5/15
|
14.3%
4/28
|
|
Nervous system disorders
Tremor
|
0.00%
0/15
|
3.6%
1/28
|
|
Psychiatric disorders
Anxiety
|
13.3%
2/15
|
0.00%
0/28
|
|
Psychiatric disorders
Depression
|
20.0%
3/15
|
0.00%
0/28
|
|
Psychiatric disorders
Insomnia
|
46.7%
7/15
|
28.6%
8/28
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/15
|
7.1%
2/28
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15
|
0.00%
0/28
|
|
Renal and urinary disorders
Urinary tract pain
|
6.7%
1/15
|
0.00%
0/28
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/15
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.7%
1/15
|
17.9%
5/28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/15
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15
|
32.1%
9/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.7%
7/15
|
21.4%
6/28
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
13.3%
2/15
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
1/15
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/15
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
73.3%
11/15
|
60.7%
17/28
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
2/15
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
1/15
|
14.3%
4/28
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.3%
2/15
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
13.3%
2/15
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/15
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/15
|
3.6%
1/28
|
|
Vascular disorders
Hypotension
|
0.00%
0/15
|
3.6%
1/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place