Trial Outcomes & Findings for Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma (NCT NCT01009515)
NCT ID: NCT01009515
Last Updated: 2017-10-18
Results Overview
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
6 months
Results posted on
2017-10-18
Participant Flow
Subjects were recruited from sites in the New Mexico Cancer Care Alliance from October, 2009 to March, 2013.
Participant milestones
| Measure |
Chemotherapy Combination
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Chemotherapy Combination
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Chemotherapy Combination
n=19 Participants
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Site of Metastasis
Brain
|
1 participants
n=5 Participants
|
|
Site of Metastasis
Bone
|
8 participants
n=5 Participants
|
|
Site of Metastasis
Liver
|
7 participants
n=5 Participants
|
|
Site of Metastasis
Lung
|
14 participants
n=5 Participants
|
|
Site of Metastasis
Other visceral organs
|
12 participants
n=5 Participants
|
|
Site of Metastasis
Regional Lymph Nodes
|
10 participants
n=5 Participants
|
|
Previous Therapy
Surgery
|
16 participants
n=5 Participants
|
|
Previous Therapy
Radiation
|
8 participants
n=5 Participants
|
|
Previous Therapy
Chemotherapy
|
4 participants
n=5 Participants
|
|
Previous Therapy
Interferon
|
5 participants
n=5 Participants
|
|
Previous Therapy
Immune Vaccines
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.
Outcome measures
| Measure |
Chemotherapy Combination
n=16 Participants
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Objective Response Rate (ORR)
Complete response (CR)
|
1 participants
|
|
Objective Response Rate (ORR)
Partial response (PR)
|
3 participants
|
|
Objective Response Rate (ORR)
Stable disease
|
0 participants
|
|
Objective Response Rate (ORR)
Progressive disease (PD)
|
12 participants
|
|
Objective Response Rate (ORR)
ORR (CR + PR)
|
4 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The 16 patients who completed treatment were evaluable for survival analysis.
The time from treatment initiation to death by any cause.
Outcome measures
| Measure |
Chemotherapy Combination
n=16 Participants
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Overall Survival
|
47 weeks
Interval 24.0 to 69.0
|
SECONDARY outcome
Timeframe: Up to 30 days after last on-study treatment, for up to 2 yearsPopulation: All patients who had received at least one dose of on-study treatment were evaluable for toxicity.
All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.
Outcome measures
| Measure |
Chemotherapy Combination
n=19 Participants
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Safety Profile
Fatigue (Grade 1-2)
|
9 participants
|
|
Safety Profile
Fatigue (Grade 3-4)
|
1 participants
|
|
Safety Profile
Fever (Grade 1-2)
|
0 participants
|
|
Safety Profile
Fever (Grade 3-4)
|
1 participants
|
|
Safety Profile
Weight loss (Grade 1-2)
|
0 participants
|
|
Safety Profile
Weight loss (Grade 3-4)
|
1 participants
|
|
Safety Profile
Anorexia (Grade 1-2)
|
1 participants
|
|
Safety Profile
Anorexia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Diarrhea (Grade 1-2)
|
5 participants
|
|
Safety Profile
Diarrhea (Grade 3-4)
|
1 participants
|
|
Safety Profile
Aspartate aminotransferase increased (Grade 1-2)
|
2 participants
|
|
Safety Profile
Aspartate aminotransferase increased (Grade 3-4)
|
1 participants
|
|
Safety Profile
Vomiting (Grade 1-2)
|
2 participants
|
|
Safety Profile
Vomiting (Grade 3-4)
|
1 participants
|
|
Safety Profile
Gastrointestinal Bleed (Grade 1-2)
|
0 participants
|
|
Safety Profile
Gastrointestinal Bleed (Grade 3-4)
|
1 participants
|
|
Safety Profile
Nausea (Grade 1-2)
|
12 participants
|
|
Safety Profile
Nausea (Grade 3-4)
|
0 participants
|
|
Safety Profile
Alanine aminotransferase increased (Grade 1-2)
|
2 participants
|
|
Safety Profile
Alanine aminotransferase increased (Grade 3-4)
|
0 participants
|
|
Safety Profile
Hyperbilirubinemia (Grade 1-2)
|
1 participants
|
|
Safety Profile
Hyperbilirubinemia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Neutropenia (Grade 1-2)
|
3 participants
|
|
Safety Profile
Neutropenia (Grade 3-4)
|
2 participants
|
|
Safety Profile
Anemia (Grade 1-2)
|
4 participants
|
|
Safety Profile
Anemia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Lymphopenia (Grade 1-2)
|
4 participants
|
|
Safety Profile
Lymphopenia (Grade 3-4)
|
1 participants
|
|
Safety Profile
Leukopenia (Grade 1-2)
|
7 participants
|
|
Safety Profile
Leukopenia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Thrombocytopenia (Grade 1-2)
|
3 participants
|
|
Safety Profile
Thrombocytopenia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Hyperglycemia (Grade 1-2)
|
3 participants
|
|
Safety Profile
Hyperglycemia (Grade 3-4)
|
1 participants
|
|
Safety Profile
Hypophosphatemia (Grade 1-2)
|
0 participants
|
|
Safety Profile
Hypophosphatemia (Grade 3-4)
|
1 participants
|
|
Safety Profile
Hypokalemia (Grade 1-2)
|
3 participants
|
|
Safety Profile
Hypokalemia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Hyponatremia (Grade 1-2)
|
3 participants
|
|
Safety Profile
Hyponatremia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Chest wall pain (Grade 1-2)
|
1 participants
|
|
Safety Profile
Chest wall pain (Grade 3-4)
|
1 participants
|
|
Safety Profile
Bone pain (Grade 1-2)
|
2 participants
|
|
Safety Profile
Bone pain (Grade 3-4)
|
0 participants
|
|
Safety Profile
Muscle weakness, lower limb (Grade 1-2)
|
2 participants
|
|
Safety Profile
Muscle weakness, lower limb (Grade 3-4)
|
0 participants
|
|
Safety Profile
Joint pain (Grade 1-2)
|
1 participants
|
|
Safety Profile
Joint pain (Grade 3-4)
|
0 participants
|
|
Safety Profile
Drowsiness (Grade 1-2)
|
0 participants
|
|
Safety Profile
Drowsiness (Grade 3-4)
|
1 participants
|
|
Safety Profile
Peripheral Sensory Neuropathy (Grade 1-2)
|
3 participants
|
|
Safety Profile
Peripheral Sensory Neutropenia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Pericardial effusion (Grade 1-2)
|
0 participants
|
|
Safety Profile
Pericardial effusion (Grade 3-4)
|
1 participants
|
|
Safety Profile
Edema limbs (Grade 1-2)
|
1 participants
|
|
Safety Profile
Edema limbs (Grade 3-4)
|
0 participants
|
|
Safety Profile
Alopecia (Grade 1-2)
|
8 participants
|
|
Safety Profile
Alopecia (Grade 3-4)
|
0 participants
|
|
Safety Profile
Rash (Grade 1-2)
|
4 participants
|
|
Safety Profile
Rash (Grade 3-4)
|
0 participants
|
|
Safety Profile
Dry mouth (Grade 1-2)
|
3 participants
|
|
Safety Profile
Dry mouth (Grade 3-4)
|
0 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The 16 patients who completed treatment were evaluable for progression-free survival.
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Chemotherapy Combination
n=16 Participants
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Time to Progression
|
31 weeks
Interval 19.0 to 58.0
|
Adverse Events
Chemotherapy Combination
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy Combination
n=19 participants at risk
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Death
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Induration
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Chemotherapy Combination
n=19 participants at risk
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles
|
|---|---|
|
Immune system disorders
Allergic reaction
|
5.3%
1/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin levels decreased
|
21.1%
4/19 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukopenia (leukocytes decreased)
|
36.8%
7/19 • Number of events 8
|
|
Blood and lymphatic system disorders
Lymphopenia (lymphocytes decreased)
|
26.3%
5/19 • Number of events 5
|
|
Blood and lymphatic system disorders
Neutrophils decreased
|
15.8%
3/19 • Number of events 6
|
|
Blood and lymphatic system disorders
Platelets decreased
|
26.3%
5/19 • Number of events 5
|
|
Cardiac disorders
Hypotension (Low blood pressure)
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Sinus tachycardia
|
15.8%
3/19 • Number of events 5
|
|
General disorders
Fatigue
|
52.6%
10/19 • Number of events 12
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Rigors/chills
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Weight loss
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia (Hair loss)
|
42.1%
8/19 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other: Folliculitis
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus (Itching)
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.1%
4/19 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Increased sweating
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distention
|
5.3%
1/19 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia (Decreased appetite)
|
5.3%
1/19 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
21.1%
4/19 • Number of events 4
|
|
Gastrointestinal disorders
Dehydration
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
5/19 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia (Indigestion)
|
5.3%
1/19 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
68.4%
13/19 • Number of events 24
|
|
Gastrointestinal disorders
Taste alteration
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2
|
|
Renal and urinary disorders
Bladder hemorrhage
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Infection
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema limbs
|
10.5%
2/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Localized edema
|
5.3%
1/19 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
21.1%
4/19 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19 • Number of events 7
|
|
Investigations
Creatinine increased
|
15.8%
3/19 • Number of events 3
|
|
Investigations
Hyperbilirubinemia (high bilirubin levels)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Hypercalcemia (high calcium levels)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Hyperglycemia (high blood sugar)
|
36.8%
7/19 • Number of events 9
|
|
Investigations
Hyperkalemia (high potassium levels)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Hypermagnesemia (high magnesium levels)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Hypoalbuminemia (low albumin protein levels)
|
10.5%
2/19 • Number of events 3
|
|
Investigations
Hypocalcemia (low calcium levels)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Hypokalemia (low potassium levels)
|
21.1%
4/19 • Number of events 4
|
|
Investigations
Hypomagnesemia (low magnesium levels)
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Hyponatremia (low sodium levels)
|
21.1%
4/19 • Number of events 5
|
|
Investigations
Hypophosphatemia (low phosphate levels)
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Increased lactate dehydrogenase levels
|
21.1%
4/19 • Number of events 6
|
|
Investigations
Laboratory test abnormal
|
5.3%
1/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
10.5%
2/19 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19 • Number of events 2
|
|
Psychiatric disorders
Depressed level of consciousness
|
5.3%
1/19 • Number of events 3
|
|
Psychiatric disorders
Depression
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Headache
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.8%
3/19 • Number of events 5
|
|
General disorders
Ear, nose and throat examination abnormal
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Abdominal pain
|
5.3%
1/19 • Number of events 2
|
|
General disorders
Back pain
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Bone pain
|
15.8%
3/19 • Number of events 6
|
|
General disorders
Buttock pain
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Chest wall pain
|
5.3%
1/19 • Number of events 2
|
|
General disorders
Joint pain
|
5.3%
1/19 • Number of events 3
|
|
General disorders
Neck pain
|
5.3%
1/19 • Number of events 2
|
|
General disorders
Pain - Other
|
15.8%
3/19 • Number of events 5
|
|
General disorders
Pain in extremity
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Pharyngolaryngeal pain (throat pain)
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
15.8%
3/19 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (low blood oxygen)
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
10.5%
2/19 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency increased
|
5.3%
1/19 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency decreased
|
5.3%
1/19 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place