Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) with a Sequential Switch to a 2nd IMT (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Study identifier:D4191C00011

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase IIa, Open-Label, Multi-Center, Multi-Cohort, Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) with a Sequential Switch to a 2nd IMT (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)

Medical condition

Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)

Phase

Phase 2

Healthy volunteers

Study drug

Gefitinib, AZD9291, Selumetinib+Docetaxel, Tremelimumab

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 25 Jul 2014

Primary Completion Date: 11 Jun 2016

Study Completion Date: 11 Jun 2016

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2019 by AstraZeneca

Collaborators

Quintiles

Inclusion and exclusion criteria

Location

Research Site

Spokane, WA, United States, 99208-1129

Location

Research Site

Augusta, GA, United States, 30912

Location

Research Site

St Louis, MO, United States, 63110

Location

Research Site

Tacoma, WA, United States, 98405

Location

Research Site

Mineola, NY, United States, 11501

Location

Research Site

Washington, DC, United States, 20007

Location

Research Site

Marietta, GA, United States, 30060

Location

Research Site

Ashland, KY, United States, 41101

Arms	Assigned Interventions
Experimental: Gefitinib with a Seq. Switch to a MEDI4736 Gefitinib once daily followed by MEDI4736	Drug: Gefitinib Gefitinib once daily followed by MEDI4736
Experimental: AZD9291 with a Seq. Switch to a MEDI4736 AZD9291 once daily followed by MEDI4736	Drug: AZD9291 AZD9291 once daily followed by MEDI4736
Experimental: Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736 Selumetinib twice daily + docetaxel, followed by MEDI4736	Drug: Selumetinib+Docetaxel Selumetinib twice daily + docetaxel, followed by MEDI4736
Experimental: Tremelimumab with a Seq. Switch to a MEDI4736 Tremelimumab every 4 weeks followed by MEDI4736	Drug: Tremelimumab Tremelimumab every 4 weeks followed by MEDI4736

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 10 study centers in United States. The first subject was enrolled on 25 July 2014.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to the small numbers of patients treated in Cohorts A through C (gefitinib, AZD9291, or selumetinib + docetaxel), statistical analyses were only done and summary tables prepared for the 28 patients randomised to Cohort D (tremelimumab, either 1-cycle or 2-cycles).

Reporting Groups

	Description
Gefitinib with a Seq. Switch to a MEDI4736	Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
AZD9291 with a Seq. Switch to a MEDI4736	The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.
Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736	Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736	Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736	Tremelimumab every 4 weeks (2 cycles) followed by MEDI4736

Participant Flow: Overall Study

	Gefitinib with a Seq. Switch to a MEDI4736	AZD9291 with a Seq. Switch to a MEDI4736	Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736	Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736	Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736
STARTED	1	1	2	14	14
COMPLETED	0	0	1	1	1
NOT COMPLETED	1	1	1	13	13

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database. Because the AZD9291 with a Seq. Switch to a MEDI4736 arm had no data recorded during the study, this arm is not included in the reporting of adverse events.

Reporting Groups

	Description
Gefitinib with a Seq. Switch to a MEDI4736	Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736	Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736	Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736	TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS
AZD9291 with a Seq. Switch to a MEDI4736	The 1 patient in the AZD9291 cohort was not dosed and no baseline data were recorded in the database.

Baseline Measures

	Gefitinib with a Seq. Switch to a MEDI4736	Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736	Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736	Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736	AZD9291 with a Seq. Switch to a MEDI4736	Total
Number of Participants [units: Participants]	1	2	14	13	0	30
Age Continuous [units: Years] Mean ± Standard Deviation	79.0 ± 0	65.0 ± 12.73	57.8 ± 12.05	64.3 ± 7.85		61.8 ± 10.85
Sex: Female, Male [units: ]
Female	0	1	6	4		NaN
Male	1	1	8	9		NaN
Race, Customized [units: Participants]
White	1	2	12	11		23
Black or African American	0	0	2	2		4

Outcome Measures

1. Primary Outcome Measure: Confirmed complete response (CR) rate [ Time Frame: Up to 2 years ]

Measure Type	Primary
Measure Name	Confirmed complete response (CR) rate
Measure Description	To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.
Time Frame	Up to 2 years
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

2. Secondary Outcome Measure: Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Measure Type	Secondary
Measure Name	Objective response rate (ORR)
Measure Description	To further assess the efficacy of various sequences. Objective response rate (ORR; per RECIST 1.1 as assessed by the site Investigator) is defined as the number (%) of patients with a confirmed overall response of CR or PR and was based on the evaluable analysis set. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	Up to 2 years
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

3. Secondary Outcome Measure: Progression-free survival [ Time Frame: Up to 2 years ]

Measure Type	Secondary
Measure Name	Progression-free survival
Measure Description	Progression-free survival (per RECIST 1.1 as assessed by Investigator) is defined as the date of 1st dose of MEDI4736 until the date of objective disease progression or death. Progression of disease (PD) At least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time Frame	Up to 2 years
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

4. Secondary Outcome Measure: Duration of response [ Time Frame: Within 12 months ]

Measure Type	Secondary
Measure Name	Duration of response
Measure Description	Duration of response (DoR; per RECIST 1.1 as assessed by the site Investigator) will be defined as the time from the date of 1st documented response (which is subsequently confirmed) until the 1st date of documented progression or death in the absence of disease progression.
Time Frame	Within 12 months
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

5. Secondary Outcome Measure: Overall survival [ Time Frame: Up to 2 years ]

Measure Type	Secondary
Measure Name	Overall survival
Measure Description	To assess the efficacy of various sequences. In survival follow up at data cut off.
Time Frame	Up to 2 years
Safety Issue?

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No text entered.

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Gefitinib with a Seq. Switch to a MEDI4736	Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736	Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
AZD9291 With a Seq. Switch to MEDI4736	The 1 patient in the AZD9291 cohort was not dosed and no data were recorded in the database.
Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736	Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736	TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS

Serious Adverse Events

Gefitinib with a Seq. Switch to a MEDI4736

Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736

AZD9291 With a Seq. Switch to MEDI4736

Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736

Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736

Total, serious adverse events

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

5/14 (35.71%)

8/13 (61.54%)

Cardiac disorders

Acute myocardial infarction¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Cardiac disorders

Pericardial effusion¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Gastric ulcer haemorrhage¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Oesophageal obstruction¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Rectal haemorrhage¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

General disorders and administration site conditions

Chest pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

General disorders and administration site conditions

Systemic inflammatory response syndrome¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Infections and infestations

Enterocolitis infectious¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Infections and infestations

Parainfluenzae virus infection¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

1/13 (7.69%)

# events

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Metabolism and nutrition disorders

Hypercalcaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Metabolism and nutrition disorders

Hyperkalaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour haemorrhage¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Brain oedema¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Seizure¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Vascular disorders

Peripheral arterial occlusive disease¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 19.0

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Gefitinib with a Seq. Switch to a MEDI4736	Gefitinib once daily followed by MEDI4736 - analyses not done due to low n
Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736	Selumetinib twice daily + docetaxel, followed by MEDI4736 - analyses not done due to low n
AZD9291 With a Seq. Switch to MEDI4736	The 1 patient in the AZD9291 cohort was not dosed and no data were recorded in the database.
Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736	Tremelimumab every 4 weeks (1 cycle) followed by MEDI4736
Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736	TREMELIMUMAB 10MG/KG Q4W 8WEEKS/MEDI4736 10MG/KG Q2W 12MONTHS

Other Adverse Events

Gefitinib with a Seq. Switch to a MEDI4736

Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736

AZD9291 With a Seq. Switch to MEDI4736

Tremelimumab (1 cycle) with a Seq. Switch to a MEDI4736

Tremelimumab (2 cycles) with a Seq. Switch to MEDI4736

Total, other (not including serious) adverse events

# participants affected / at risk

1/1 (100.00%)

2/2 (100.00%)

0/0

13/14 (92.86%)

13/13 (100.00%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

2/14 (14.29%)

4/13 (30.77%)

# events

Blood and lymphatic system disorders

Leukocytosis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Blood and lymphatic system disorders

Lymphadenopathy¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Blood and lymphatic system disorders

Thrombocytosis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Cardiac disorders

Atrial tachycardia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Cardiac disorders

Bradycardia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Cardiac disorders

Mitral valve stenosis¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Cardiac disorders

Palpitations¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Cardiac disorders

Pericardial effusion¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Cardiac disorders

Sinus tachycardia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Cardiac disorders

Tachycardia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

2/13 (15.38%)

# events

Cardiac disorders

Ventricular tachycardia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Ear and labyrinth disorders

Ear pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Ear and labyrinth disorders

Hypoacusis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Endocrine disorders

Hyperthyroidism¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Eye disorders

Eye disorder¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Eye disorders

Periorbital oedema¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Abdominal hernia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Abdominal pain lower¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

0/1 (0.00%)

2/2 (100.00%)

0/0

3/14 (21.43%)

2/13 (15.38%)

# events

Gastrointestinal disorders

Dental caries¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

0/1 (0.00%)

2/2 (100.00%)

0/0

6/14 (42.86%)

3/13 (23.08%)

# events

Gastrointestinal disorders

Dry mouth¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

0/1 (0.00%)

2/2 (100.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Gastrointestinal disorders

Haematochezia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

4/14 (28.57%)

4/13 (30.77%)

# events

Gastrointestinal disorders

Periodontal disease¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Stomatitis¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

2/14 (14.29%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Tongue discolouration¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/1 (0.00%)

2/2 (100.00%)

0/0

4/14 (28.57%)

3/13 (23.08%)

# events

General disorders and administration site conditions

Chills¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

2/14 (14.29%)

2/13 (15.38%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

1/1 (100.00%)

1/2 (50.00%)

0/0

6/14 (42.86%)

5/13 (38.46%)

# events

General disorders and administration site conditions

Gait disturbance¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

General disorders and administration site conditions

Inflammation¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

0/13 (0.00%)

# events

General disorders and administration site conditions

Local swelling¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

General disorders and administration site conditions

Mucosal inflammation¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

5/13 (38.46%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

3/14 (21.43%)

1/13 (7.69%)

# events

Infections and infestations

Candida infection¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Infections and infestations

Clostridium difficile colitis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Furuncle¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Infections and infestations

Implant site infection¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Rash pustular¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Rhinitis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

1/13 (7.69%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Injury, poisoning and procedural complications

Lower limb fracture¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Investigations

Blood glucose increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Investigations

Blood lactate dehydrogenase increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Investigations

Blood sodium increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Investigations

Blood thyroid stimulating hormone increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Investigations

Blood urea increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Investigations

Weight decreased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

4/13 (30.77%)

# events

Investigations

White blood cell count increased¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

3/14 (21.43%)

3/13 (23.08%)

# events

Metabolism and nutrition disorders

Dehydration¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

3/13 (23.08%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Metabolism and nutrition disorders

Hyperkalaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Metabolism and nutrition disorders

Hypernatraemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Metabolism and nutrition disorders

Hypoalbuminaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

2/13 (15.38%)

# events

Metabolism and nutrition disorders

Hypocalcaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

3/13 (23.08%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

3/14 (21.43%)

4/13 (30.77%)

# events

Metabolism and nutrition disorders

Hypomagnesaemia¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

3/13 (23.08%)

# events

Metabolism and nutrition disorders

Metabolic acidosis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

2/13 (15.38%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

0/1 (0.00%)

2/2 (100.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour flare¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

1/13 (7.69%)

# events

Nervous system disorders

Amnesia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Aphasia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Nervous system disorders

Encephalopathy¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

3/13 (23.08%)

# events

Nervous system disorders

Peripheral sensory neuropathy¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

0/13 (0.00%)

# events

Product issues

Thrombosis in device¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Psychiatric disorders

Agitation¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

2/13 (15.38%)

# events

Psychiatric disorders

Confusional state¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

2/13 (15.38%)

# events

Psychiatric disorders

Delirium¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

1/13 (7.69%)

# events

Renal and urinary disorders

Chronic kidney disease¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Renal and urinary disorders

Micturition urgency¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Renal and urinary disorders

Pollakiuria¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Renal and urinary disorders

Urethral pain¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

5/14 (35.71%)

2/13 (15.38%)

# events

Respiratory, thoracic and mediastinal disorders

Dysphonia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

2/13 (15.38%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

3/13 (23.08%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

2/13 (15.38%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoxia¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

2/13 (15.38%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal dryness¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonitis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumothorax¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Rales¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Upper-airway cough syndrome¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Respiratory, thoracic and mediastinal disorders

Wheezing¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

4/13 (30.77%)

# events

Skin and subcutaneous tissue disorders

Dry skin¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

0/13 (0.00%)

# events

Skin and subcutaneous tissue disorders

Hyperhidrosis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

1/13 (7.69%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

3/13 (23.08%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

0/1 (0.00%)

2/2 (100.00%)

0/0

3/14 (21.43%)

2/13 (15.38%)

# events

Skin and subcutaneous tissue disorders

Rash maculo-papular¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

2/14 (14.29%)

0/13 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash pruritic¹,^†

# participants affected / at risk

1/1 (100.00%)

0/2 (0.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Skin and subcutaneous tissue disorders

Skin necrosis¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Skin and subcutaneous tissue disorders

Urticaria¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Vascular disorders

Flushing¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Vascular disorders

Haematoma¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Vascular disorders

Hot flush¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

0/13 (0.00%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/1 (0.00%)

1/2 (50.00%)

0/0

1/14 (7.14%)

1/13 (7.69%)

# events

Vascular disorders

Lymphoedema¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

Vascular disorders

Orthostatic hypotension¹,^†

# participants affected / at risk

0/1 (0.00%)

0/2 (0.00%)

0/0

0/14 (0.00%)

1/13 (7.69%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 19.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Phillip Dennis
Organization:	AstraZeneca
Phone	1 + 301-398-5549
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

Cancer Study Locator

877 400 4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

Samir N. Khleif

International Coordinating Investigator

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Trial Results Summaries