Trial Outcomes & Findings for Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen. (NCT NCT02033993)
NCT ID: NCT02033993
Last Updated: 2023-08-22
Results Overview
PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
42 months
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Arm 1
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
100
|
|
Overall Study
COMPLETED
|
96
|
91
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1
n=99 Participants
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 Participants
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=199 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
43 Participants
n=100 Participants
|
81 Participants
n=199 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=99 Participants
|
57 Participants
n=100 Participants
|
118 Participants
n=199 Participants
|
|
Age, Continuous
|
67 Years
n=99 Participants
|
68 Years
n=100 Participants
|
67 Years
n=199 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
26 Participants
n=100 Participants
|
55 Participants
n=199 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
74 Participants
n=100 Participants
|
144 Participants
n=199 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
79 participants
n=99 Participants
|
81 participants
n=100 Participants
|
160 participants
n=199 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=99 Participants
|
19 participants
n=100 Participants
|
39 participants
n=199 Participants
|
PRIMARY outcome
Timeframe: 42 monthsPopulation: ITT population.
PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.
Outcome measures
| Measure |
Arm 1
n=99 Participants
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 Participants
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Progression-Free Survival
|
3.35 Months
Interval 2.69 to 4.3
|
3.02 Months
Interval 2.14 to 4.4
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: ITT piopulation
Time from randomization to the date of death due to any causes, or censored at last contact date.
Outcome measures
| Measure |
Arm 1
n=99 Participants
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 Participants
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Overall Survival
|
7.46 Months
Interval 6.44 to 8.64
|
8.77 Months
Interval 6.11 to 10.61
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: ITT population
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Clinical Benefit Rate = OR + SD \> 12 weeks.
Outcome measures
| Measure |
Arm 1
n=99 Participants
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 Participants
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Clinical Benefit Rate
|
50.5 percentage of participants
Interval 42.2 to 58.8
|
43 percentage of participants
Interval 34.9 to 51.1
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: ITT population
Time from the date of randomkization to the date of objective response according to RECIST Response Criteria was first achieved.
Outcome measures
| Measure |
Arm 1
n=99 Participants
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 Participants
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Time to Response
|
17.5 Months
Interval 5.49 to 17.5
|
35.8 Months
Interval 0.03 to 42.0
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: Patients with baseline and at least 1 after treatment evaluation.
Quality of life will be assessed using the EORTC-C15-PAL questionnaire plus additional study specific questions. Changes in quality of life scores while on treatment (compared to baseline scores) will be examined using descriptive analyses and inferential statistics. The primary test to compare treatment arms will be the NCIC CTG Quality of Life Committee suggested response analyses. A change score of 10 points from baseline was defined as clinically relevant. Patients were considered improved if reported a score 10-points or better than baseline at any time point in QoL assessment. Conversely, patients were considered worsened if reported a score minus 10-points or worse than baseline at any time point in QOL assessment without the above-defined improvement being observed. Patients whose scores were between 10-point changes from baseline at every QoL assessment were considered as stable.
Outcome measures
| Measure |
Arm 1
n=85 Participants
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=75 Participants
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Health Related Quality of Life Evaluated Using EORTC-C15-Pal
Improved
|
28 Participants
|
22 Participants
|
|
Health Related Quality of Life Evaluated Using EORTC-C15-Pal
Stable
|
7 Participants
|
13 Participants
|
|
Health Related Quality of Life Evaluated Using EORTC-C15-Pal
Worsen
|
50 Participants
|
40 Participants
|
Adverse Events
Arm 1
Serious events: 28 serious events
Other events: 96 other events
Deaths: 72 deaths
Arm 2
Serious events: 19 serious events
Other events: 97 other events
Deaths: 67 deaths
Serious adverse events
| Measure |
Arm 1
n=99 participants at risk
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 participants at risk
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.1%
6/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/99 • 42 months
The CTC version 4.0
|
2.0%
2/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
General disorders
Death NOS
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
General disorders
Edema limbs
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
General disorders
Fatigue
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
2.0%
2/100 • 42 months
The CTC version 4.0
|
|
General disorders
Fever
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
3.0%
3/100 • 42 months
The CTC version 4.0
|
|
General disorders
Pain
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Immune system disorders
Allergic reaction
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Immune system disorders
Anaphylaxis
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Device related infection
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Kidney infection
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Lung infection
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Sepsis
|
3.0%
3/99 • 42 months
The CTC version 4.0
|
4.0%
4/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Skin infection
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Urinary tract infection
|
7.1%
7/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Other nervous system disorders
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Psychiatric disorders
Confusion
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Hematuria
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
2.0%
2/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
2/99 • 42 months
The CTC version 4.0
|
2.0%
2/100 • 42 months
The CTC version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
2.0%
2/100 • 42 months
The CTC version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
0.00%
0/100 • 42 months
The CTC version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
Other adverse events
| Measure |
Arm 1
n=99 participants at risk
Nab-Paclitaxel - 260mg/m2: q21 days
Nab-Paclitaxel
|
Arm 2
n=100 participants at risk
Paclitaxel - 175mg/m2: q21 days
Paclitaxel
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
46.5%
46/99 • 42 months
The CTC version 4.0
|
44.0%
44/100 • 42 months
The CTC version 4.0
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
7/99 • 42 months
The CTC version 4.0
|
4.0%
4/100 • 42 months
The CTC version 4.0
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.0%
3/99 • 42 months
The CTC version 4.0
|
8.0%
8/100 • 42 months
The CTC version 4.0
|
|
Ear and labyrinth disorders
Tinnitus
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Eye disorders
Blurred vision
|
7.1%
7/99 • 42 months
The CTC version 4.0
|
4.0%
4/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Abdominal pain
|
19.2%
19/99 • 42 months
The CTC version 4.0
|
29.0%
29/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Constipation
|
58.6%
58/99 • 42 months
The CTC version 4.0
|
55.0%
55/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Diarrhea
|
34.3%
34/99 • 42 months
The CTC version 4.0
|
27.0%
27/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
10/99 • 42 months
The CTC version 4.0
|
9.0%
9/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
8.0%
8/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Mucositis oral
|
14.1%
14/99 • 42 months
The CTC version 4.0
|
8.0%
8/100 • 42 months
The CTC version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
22/99 • 42 months
The CTC version 4.0
|
19.0%
19/100 • 42 months
The CTC version 4.0
|
|
General disorders
Chills
|
7.1%
7/99 • 42 months
The CTC version 4.0
|
2.0%
2/100 • 42 months
The CTC version 4.0
|
|
General disorders
Edema limbs
|
22.2%
22/99 • 42 months
The CTC version 4.0
|
22.0%
22/100 • 42 months
The CTC version 4.0
|
|
General disorders
Fatigue
|
71.7%
71/99 • 42 months
The CTC version 4.0
|
80.0%
80/100 • 42 months
The CTC version 4.0
|
|
General disorders
Fever
|
15.2%
15/99 • 42 months
The CTC version 4.0
|
13.0%
13/100 • 42 months
The CTC version 4.0
|
|
General disorders
Flu like symptoms
|
10.1%
10/99 • 42 months
The CTC version 4.0
|
3.0%
3/100 • 42 months
The CTC version 4.0
|
|
General disorders
Non-cardiac chest pain
|
3.0%
3/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
General disorders
Pain
|
9.1%
9/99 • 42 months
The CTC version 4.0
|
12.0%
12/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
4/99 • 42 months
The CTC version 4.0
|
9.0%
9/100 • 42 months
The CTC version 4.0
|
|
Infections and infestations
Urinary tract infection
|
21.2%
21/99 • 42 months
The CTC version 4.0
|
17.0%
17/100 • 42 months
The CTC version 4.0
|
|
Investigations
Weight loss
|
14.1%
14/99 • 42 months
The CTC version 4.0
|
9.0%
9/100 • 42 months
The CTC version 4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
46.5%
46/99 • 42 months
The CTC version 4.0
|
44.0%
44/100 • 42 months
The CTC version 4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
9/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.0%
4/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.3%
25/99 • 42 months
The CTC version 4.0
|
26.0%
26/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.2%
21/99 • 42 months
The CTC version 4.0
|
34.0%
34/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
11/99 • 42 months
The CTC version 4.0
|
16.0%
16/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.1%
6/99 • 42 months
The CTC version 4.0
|
8.0%
8/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.1%
6/99 • 42 months
The CTC version 4.0
|
9.0%
9/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
12.1%
12/99 • 42 months
The CTC version 4.0
|
7.0%
7/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.2%
21/99 • 42 months
The CTC version 4.0
|
22.0%
22/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.2%
17/99 • 42 months
The CTC version 4.0
|
29.0%
29/100 • 42 months
The CTC version 4.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Dizziness
|
16.2%
16/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Dysgeusia
|
15.2%
15/99 • 42 months
The CTC version 4.0
|
15.0%
15/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Headache
|
13.1%
13/99 • 42 months
The CTC version 4.0
|
13.0%
13/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Paresthesia
|
10.1%
10/99 • 42 months
The CTC version 4.0
|
3.0%
3/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.1%
6/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
72.7%
72/99 • 42 months
The CTC version 4.0
|
64.0%
64/100 • 42 months
The CTC version 4.0
|
|
Psychiatric disorders
Anxiety
|
17.2%
17/99 • 42 months
The CTC version 4.0
|
17.0%
17/100 • 42 months
The CTC version 4.0
|
|
Psychiatric disorders
Depression
|
7.1%
7/99 • 42 months
The CTC version 4.0
|
12.0%
12/100 • 42 months
The CTC version 4.0
|
|
Psychiatric disorders
Insomnia
|
37.4%
37/99 • 42 months
The CTC version 4.0
|
24.0%
24/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Hematuria
|
11.1%
11/99 • 42 months
The CTC version 4.0
|
11.0%
11/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
1.0%
1/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
7/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Urinary tract obstruction
|
15.2%
15/99 • 42 months
The CTC version 4.0
|
11.0%
11/100 • 42 months
The CTC version 4.0
|
|
Renal and urinary disorders
Urinary tract pain
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Reproductive system and breast disorders
Pelvic pain
|
12.1%
12/99 • 42 months
The CTC version 4.0
|
13.0%
13/100 • 42 months
The CTC version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.2%
19/99 • 42 months
The CTC version 4.0
|
27.0%
27/100 • 42 months
The CTC version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.3%
31/99 • 42 months
The CTC version 4.0
|
32.0%
32/100 • 42 months
The CTC version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
2/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
62.6%
62/99 • 42 months
The CTC version 4.0
|
62.0%
62/100 • 42 months
The CTC version 4.0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
3/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
8/99 • 42 months
The CTC version 4.0
|
5.0%
5/100 • 42 months
The CTC version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.1%
10/99 • 42 months
The CTC version 4.0
|
14.0%
14/100 • 42 months
The CTC version 4.0
|
|
Vascular disorders
Hot flashes
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
6.0%
6/100 • 42 months
The CTC version 4.0
|
|
Vascular disorders
Hypertension
|
6.1%
6/99 • 42 months
The CTC version 4.0
|
3.0%
3/100 • 42 months
The CTC version 4.0
|
|
Vascular disorders
Hypotension
|
5.1%
5/99 • 42 months
The CTC version 4.0
|
1.0%
1/100 • 42 months
The CTC version 4.0
|
|
Vascular disorders
Thromboembolic event
|
9.1%
9/99 • 42 months
The CTC version 4.0
|
10.0%
10/100 • 42 months
The CTC version 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place