Trial Outcomes & Findings for A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer (NCT NCT02087176)
NCT ID: NCT02087176
Last Updated: 2016-06-14
Results Overview
Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to \< 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Up to 20 months
Results posted on
2016-06-14
Participant Flow
The study was conducted at 12 clinical sites in the United States. A total of 32 subjects were enrolled between May 20, 2014 and January 22, 2015.
48 participants were screened. 16 did not meet criteria. In Part A, 32 participants were enrolled. The study was terminated early by the sponsor. Part B of the study was not done.
Participant milestones
| Measure |
Part A: AZD1775 Plus Docetaxel
Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Part A: AZD1775 Plus Docetaxel
Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
10
|
|
Overall Study
Censored
|
19
|
|
Overall Study
Study Terminated by Sponsor
|
2
|
Baseline Characteristics
A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
Baseline characteristics by cohort
| Measure |
Part A: AZD1775 Plus Docetaxel
n=32 Participants
Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
|
|---|---|
|
Age, Continuous
|
62.0 Years
n=5 Participants
|
|
Age, Customized
< 65
|
18 Participants
n=5 Participants
|
|
Age, Customized
>= 65
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
|
Tobacco Use
Smoker
|
29 Participants
n=5 Participants
|
|
Tobacco Use
Non-Smoker
|
1 Participants
n=5 Participants
|
|
Tobacco Use
Smoking Status Missing
|
2 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status = 0
|
15 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status = 1
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 20 monthsPopulation: Thirty-two (32) subjects were enrolled in Part A, but the study was terminated early. Patients on-study at the time the study was terminated have been censored.
Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to \< 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part A: AZD1775 Plus Docetaxel
n=32 Participants
Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
|
|---|---|
|
Objective Response Rate
|
9.4 Percentage of Participants
Interval 2.6 to 22.5
|
SECONDARY outcome
Timeframe: Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicityPopulation: The study was terminated early by the sponsor. Pharmacokinetic data have not been analyzed.
Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose. However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Part A: AZD1775 Plus Docetaxel
Serious events: 17 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: AZD1775 Plus Docetaxel
n=32 participants at risk
Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
2/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 3 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Asthenia
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Partial Seizures
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Vascular disorders
Haemorrhage
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Investigations
Neutrophil Count Decreased
|
3.1%
1/32 • Number of events 1 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
Other adverse events
| Measure |
Part A: AZD1775 Plus Docetaxel
n=32 participants at risk
Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
16/32 • Number of events 34 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.9%
7/32 • Number of events 8 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.2%
10/32 • Number of events 16 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.4%
11/32 • Number of events 24 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.6%
5/32 • Number of events 7 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Abdominal Pain, Upper
|
12.5%
4/32 • Number of events 7 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
4/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Diarrhoea
|
65.6%
21/32 • Number of events 39 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Nausea
|
46.9%
15/32 • Number of events 27 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Stomatitis
|
9.4%
3/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Gastrointestinal disorders
Vomiting
|
43.8%
14/32 • Number of events 19 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Asthenia
|
21.9%
7/32 • Number of events 13 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Chest Pain
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Chills
|
15.6%
5/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Face Oedema
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Fatigue
|
43.8%
14/32 • Number of events 25 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Malaise
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Mucosal Inflammation
|
12.5%
4/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Oedema Peripheral
|
9.4%
3/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Pain
|
21.9%
7/32 • Number of events 10 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
General disorders
Pyrexia
|
25.0%
8/32 • Number of events 10 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.6%
5/32 • Number of events 8 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Investigations
Platelet Count Decreased
|
12.5%
4/32 • Number of events 9 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Investigations
Weight Decreased
|
21.9%
7/32 • Number of events 7 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
31.2%
10/32 • Number of events 12 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Dehydration
|
31.2%
10/32 • Number of events 18 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.4%
3/32 • Number of events 7 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
4/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.4%
3/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.9%
7/32 • Number of events 8 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.6%
5/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
18.8%
6/32 • Number of events 8 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Number of events 3 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.5%
4/32 • Number of events 6 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • Number of events 6 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Dysgeusia
|
15.6%
5/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 5 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Neuropathy, Peripheral
|
9.4%
3/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Nervous system disorders
Syncope
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Psychiatric disorders
Confusional State
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Psychiatric disorders
Depression
|
9.4%
3/32 • Number of events 3 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Psychiatric disorders
Insomnia
|
18.8%
6/32 • Number of events 6 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
4/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.6%
5/32 • Number of events 6 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea, Exertional
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxsis
|
15.6%
5/32 • Number of events 6 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
2/32 • Number of events 3 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
9.4%
3/32 • Number of events 3 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Cough Syndrome
|
9.4%
3/32 • Number of events 3 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
2/32 • Number of events 2 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.1%
9/32 • Number of events 10 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Number of events 4 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
|
Vascular disorders
Hypotension
|
18.8%
6/32 • Number of events 7 • 1 year
Adverse event data were collected from the time the first patient received the first dose of investigational drug on May 20, 2014 until the study was closed on May 12, 2015.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place