Trial Outcomes & Findings for Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00536107)

NCT ID: NCT00536107

Last Updated: 2013-10-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: From time consent was given to 28 days after last dose of study drug.
• Results posted on: 2013-10-01

Participant Flow

A total of 14 patients with locally advanced or metastatic non small cell lung cancer of adenocarcinoma histology previously treated with one platinum based chemotherapy were screened and randomized.

Participant milestones

Measure	Gefitinib gefitinib 250mg	Docetaxel docetaxel 60mg/m sq
Overall Study STARTED	8	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	Gefitinib gefitinib 250mg	Docetaxel docetaxel 60mg/m sq
Overall Study Death	5	1
Overall Study Incorrect enrolment	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Study Termination	2	4

Baseline Characteristics

Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Gefitinib n=8 Participants gefitinib 250mg	Docetaxel n=6 Participants docetaxel 60mg/m sq	Total n=14 Participants Total of all reporting groups
Age Continuous	67.43 years STANDARD_DEVIATION 8.15 • n=5 Participants	54.52 years STANDARD_DEVIATION 12.34 • n=7 Participants	61.89 years STANDARD_DEVIATION 11.76 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
WHO performance status Normal activity	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
WHO performance status Restricted activity	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants
WHO performance status In bed less than or equal to 50% of time	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
WHO performance status In bed more than 50% of the time	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
WHO performance status 100% bedridden	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Weight	60.51 kg STANDARD_DEVIATION 10.35 • n=5 Participants	60.03 kg STANDARD_DEVIATION 6.4 • n=7 Participants	60.31 kg STANDARD_DEVIATION 8.57 • n=5 Participants
Height	159.3 cm STANDARD_DEVIATION 7.26 • n=5 Participants	162.77 cm STANDARD_DEVIATION 7.32 • n=7 Participants	160.79 cm STANDARD_DEVIATION 7.22 • n=5 Participants
BMI	23.84 kg/m2 STANDARD_DEVIATION 3.85 • n=5 Participants	22.77 kg/m2 STANDARD_DEVIATION 3.27 • n=7 Participants	23.39 kg/m2 STANDARD_DEVIATION 3.52 • n=5 Participants

PRIMARY outcome

Timeframe: From time consent was given to 28 days after last dose of study drug.

Population: Evaluable for Safety population: All patients who recived at least one dose of study drug

Outcome measures

Measure	Gefitinib n=8 Participants gefitinib 250mg	Docetaxel n=6 Participants docetaxel 60mg/m sq
Number of Patients With Adverse Event (AE)	8 Participants	6 Participants

PRIMARY outcome

Timeframe: From time consent was given to 28 days after last dose

Outcome measures

Measure	Gefitinib n=8 Participants gefitinib 250mg	Docetaxel n=6 Participants docetaxel 60mg/m sq
Number of Patients With Serious Adverse Events (SAEs)	2 participants	1 participants

Adverse Events

Gefitinib

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Docetaxel

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gefitinib n=8 participants at risk gefitinib 250mg	Docetaxel n=6 participants at risk docetaxel 60mg/m sq
Infections and infestations Pneumonia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Eye disorders Glaucoma	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.

Other adverse events

Measure	Gefitinib n=8 participants at risk gefitinib 250mg	Docetaxel n=6 participants at risk docetaxel 60mg/m sq
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Eye disorders Borderline glaucoma	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Eye disorders Iridocyclitis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	33.3% 2/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Gastrointestinal disorders Aphthous stomatitis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Gastrointestinal disorders Constipation	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Gastrointestinal disorders Nausea	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	33.3% 2/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Gastrointestinal disorders Vomiting	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	33.3% 2/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
General disorders Asthenia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
General disorders Chest discomfort	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
General disorders Fatigue	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
General disorders Malaise	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
General disorders Oedema peripheral	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
General disorders Pyrexia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Bronchitis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Catheter site infection	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Nasopharyngitis	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Oral candidiasis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Pneumonia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Sepsis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Tonsillitis	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Infections and infestations Upper respiratory tract infection	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Injury, poisoning and procedural complications Wound complication	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Injury, poisoning and procedural complications Wound dehiscence	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Investigations Alanine aminotransferase increased	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Investigations Aspartate aminotransferase increased	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Investigations Neutrophil count decreased	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Investigations White blood cell count decreased	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Musculoskeletal and connective tissue disorders Bone pain	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Musculoskeletal and connective tissue disorders Muscle spasms	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Nervous system disorders Convulsion	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Nervous system disorders Dizziness	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	50.0% 3/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Nervous system disorders Hypoaesthesia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Nervous system disorders Paraplegia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Psychiatric disorders Insomnia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Renal and urinary disorders Bladder disorder	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Renal and urinary disorders Dysuria	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Reproductive system and breast disorders Benign prostatic hyperplasia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Dysphonia	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Haemoptysis	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Lung disorder	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Respiratory, thoracic and mediastinal disorders Throat Irritation	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Skin and subcutaneous tissue disorders Acne	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	33.3% 2/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Skin and subcutaneous tissue disorders Dry skin	37.5% 3/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Skin and subcutaneous tissue disorders Pain of skin	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Skin and subcutaneous tissue disorders Pruritus	50.0% 4/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	0.00% 0/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.
Vascular disorders Hypertension	0.00% 0/8 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.	16.7% 1/6 • From time consent was given to 28 days after last dose of study drug Adverse event iformtaion was collectde at each study visit by Information volunteered by the patient, or the patient's care giver; open-ended and non-leading verbal questioning of the patient; and observation by the investigational team, other care providers or relatives.

Additional Information

Sharon Chang

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place