Trial Outcomes & Findings for Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer (NCT NCT04396535)
NCT ID: NCT04396535
Last Updated: 2025-11-17
Results Overview
The primary analysis of PFS will be a comparison of the Kaplan-Meier curves for docetaxel + bintrafusp alfa vs. docetaxel alone using a one-sided log-rank test.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From randomization to the first of either disease progression or death from any cause, assessed up to 3 years and 2 months
Results posted on
2025-11-17
Participant Flow
Study was projected to accrue 80 patients and only accrued 10 due to early termination of study.
Participant milestones
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Bintrafusp Alfa: Given IV\>
\>\>
\>
\>\> Docetaxel: Given IV
|
Arm II (Docetaxel)
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone.\>
\>\>
\>
\>\> Docetaxel: Given IV
|
|---|---|---|
|
Initial Study
STARTED
|
6
|
4
|
|
Initial Study
COMPLETED
|
6
|
3
|
|
Initial Study
NOT COMPLETED
|
0
|
1
|
|
Crossover
STARTED
|
0
|
1
|
|
Crossover
COMPLETED
|
0
|
1
|
|
Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 Participants
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Bintrafusp Alfa: Given IV\>\>
\>\> Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone.\>\>
\>\> Docetaxel: Given IV
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 7.44 • n=39 Participants
|
69.0 years
STANDARD_DEVIATION 8.72 • n=29 Participants
|
66.2 years
STANDARD_DEVIATION 7.61 • n=60 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
7 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
9 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
9 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Smoking Status
Current
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Smoking Status
Former
|
3 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
|
Smoking Status
Never
|
3 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
|
MedDRA Disease Code
Lung adenocarcinoma
|
6 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
MedDRA Disease Code
Squamous cell lung carcinoma
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
MedDRA Disease Code
Non-small cell lung cancer, NOS
|
0 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
ECOG Performance Status
0
|
4 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
5 Participants
n=60 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: From randomization to the first of either disease progression or death from any cause, assessed up to 3 years and 2 monthsThe primary analysis of PFS will be a comparison of the Kaplan-Meier curves for docetaxel + bintrafusp alfa vs. docetaxel alone using a one-sided log-rank test.
Outcome measures
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 Participants
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. \>
* \> \>
* \> Bintrafusp Alfa: Given IV \>
* \> \>
* \> Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone. \>
* \> \>
* \> Docetaxel: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS) of Bintrafusp Alfa in Combination With Docetaxel Versus (vs) Docetaxel Alone
|
3.0 months
Interval 1.7 to
Not enough events to calculate an upper bound
|
8.6 months
Interval 1.8 to
Not enough events to calculate an upper bound
|
SECONDARY outcome
Timeframe: From study entry to death from any cause, assessed up to 3 years and 2 monthsOS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
Outcome measures
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 Participants
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. \>
* \> \>
* \> Bintrafusp Alfa: Given IV \>
* \> \>
* \> Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone. \>
* \> \>
* \> Docetaxel: Given IV
|
|---|---|---|
|
Overall Survival (OS)
|
22.0 months
Interval 6.3 to
Not enough events to calculate an upper bound
|
16.3 months
Interval 1.8 to
Not enough events to calculate an upper bound
|
SECONDARY outcome
Timeframe: Up to 3 years and 2 monthsWill be classified as a confirmed response per the Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria, if they have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square of Fisher's Exact test.
Outcome measures
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 Participants
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. \>
* \> \>
* \> Bintrafusp Alfa: Given IV \>
* \> \>
* \> Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone. \>
* \> \>
* \> Docetaxel: Given IV
|
|---|---|---|
|
Confirmed Response Rates
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years and 2 monthsPopulation: No confirmed response for Arm II.
The duration of confirmed responses will be assessed using the Kaplan Meier method, where the duration of confirmed response will be defined as the time from the first documented date of response (complete response \[CR\] or partial response \[PR\]) to the date at which progression is first documented. Duration of response will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
Outcome measures
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=1 Participants
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. \>
* \> \>
* \> Bintrafusp Alfa: Given IV \>
* \> \>
* \> Docetaxel: Given IV
|
Arm II (Docetaxel)
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone. \>
* \> \>
* \> Docetaxel: Given IV
|
|---|---|---|
|
Duration of Response
|
5.8 months
Interval 5.8 to 5.8
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years and 2 monthsPopulation: Lower grades are better than higher grades
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Outcome measures
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 Participants
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. \>
* \> \>
* \> Bintrafusp Alfa: Given IV \>
* \> \>
* \> Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone. \>
* \> \>
* \> Docetaxel: Given IV
|
|---|---|---|
|
Incidence of Adverse Events
Grade 4+ Adverse Event
|
3 Participants
|
3 Participants
|
|
Incidence of Adverse Events
Grade 3+ Adverse Event
|
3 Participants
|
3 Participants
|
|
Incidence of Adverse Events
Grade 3+ Heme Adverse Event
|
3 Participants
|
2 Participants
|
|
Incidence of Adverse Events
Grade 3+ Non-Heme Adverse Event
|
2 Participants
|
3 Participants
|
|
Incidence of Adverse Events
Grade 4+ Heme Adverse Event
|
3 Participants
|
2 Participants
|
|
Incidence of Adverse Events
Grade 4+ Non-Heme Adverse Event
|
0 Participants
|
1 Participants
|
Adverse Events
Arm I (Docetaxel, Bintrafusp Alfa)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (Docetaxel)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm II Crossover (Docetaxel, Bintrafusp Alfa)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 participants at risk
Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 participants at risk
Docetaxel: Given IV
|
Arm II Crossover (Docetaxel, Bintrafusp Alfa)
n=1 participants at risk
Docetaxel: Given IV Docetaxel: Given IV
|
|---|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/6 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
Other adverse events
| Measure |
Arm I (Docetaxel, Bintrafusp Alfa)
n=6 participants at risk
Docetaxel: Given IV
|
Arm II (Docetaxel)
n=3 participants at risk
Docetaxel: Given IV
|
Arm II Crossover (Docetaxel, Bintrafusp Alfa)
n=1 participants at risk
Docetaxel: Given IV Docetaxel: Given IV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 5 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 5 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
ECG QT corrected interval prolonged
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
16.7%
1/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 5 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
33.3%
1/3 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 3 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 2 • Up to 3 years and 2 months
|
0.00%
0/3 • Up to 3 years and 2 months
|
0.00%
0/1 • Up to 3 years and 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place