EZN-2279 in Patients With ADA-SCID

• Sponsor: Leadiant Biosciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01420627
• Collaborator: (none)
• Enrollment: 7
• Locations: 6
• Arm: 1
• Actual Duration (Months): 64.1
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated with Adagen.

Condition or Disease	Intervention/Treatment	Phase
ADA-SCID; Adenosine Deaminase Deficiency; Severe Combined Immunodeficiency	Biological: EZN-2279; Biological: Adagen	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of EZN-2279 (Polyethylene Glycol Recombinant Adenosine Deaminase [PEG-rADA]) Administered as a Weekly Intramuscular Injection in Patients With Adenosine Deaminase (ADA)-Deficient Combined Immunodeficiency
• Actual Study Start Date: Jan 24, 2014
• Actual Primary Completion Date: Apr 10, 2018
• Actual Study Completion Date: May 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adagen/EZN-2279 Patients started on Adagen and crossed over to experimental EZN-2279 treatment after at least a 3 week Lead-in Period on Adagen	Biological: EZN-2279; Weekly administration of EZN-2279 via IM injection; Other Names: rADA ; Biological: Adagen

Outcome Measures

Primary Outcome Measures

1. Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period [Baseline through Week T-21]

   Number of patients with total erythrocyte dAXP concentration from a trough blood sample <0.02 mmol/L

Secondary Outcome Measures

1. Safety Summary Data [Through end of EZN-2279 study treatment, up to 203 weeks]

   Summary of adverse events and serious adverse events

2. Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period [From Baseline through Week T-21]

   Trough ADA activity, mmol/h/L

3. Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period [Through end of EZN-2279 study treatment, up to 203 weeks]

   Trough ADA activity levels, mmol/h/L

4. Summary of Trough dAXP Levels in EZN-2279 Treatment Period [From Baseline through Week T-21]

   Trough dAXP levels, mmol/L

5. Summary of Trough dAXP Levels in EZN-2279 Maintenance Period [Through end of EZN-2279 study treatment, up to 203 weeks]

   Trough dAXP levels, mmol/L

6. Number of Patients With Infections and Hospitalizations [Through end of EZN-2279 study treatment, up to 203 weeks]

   Infections were documented clinically with signs and symptoms without microbiologic cultures or with positive viral or bacterial cultures

7. Duration of Hospitalization [Through end of EZN-2279 study treatment, up to 203 weeks]

8. Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period [From Week 34 to End of Study/Early Discontinuation, up to 203 weeks]

   Number of patients with total erythrocyte dAXP concentration from a trough blood sample <0.02 mmol/L

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of ADA-deficient combined immunodeficiency

2. Stable clinical status while receiving therapy with Adagen®. Patients previously receiving gene therapy or undergoing hematopoietic stem cell transplantation who still require Adagen® treatment are eligible. The dose of Adagen® must be stable for at least 6 months prior to study entry.

3. Have both of the following during the Adagen® Lead-in phase of the study prior to

EZN-2279 transition:

1. Trough plasma ADA activity >15 μmol/h/mL while receiving Adagen® and

2. Total erythrocyte dAXP ≤0.02 μmol/mL from a trough blood sample

3. Patients or parent/guardian must be capable of understanding the protocol requirements and risks and providing written informed assent/consent

Exclusion Criteria:

1. Autoimmunity requiring immunosuppressive treatment

2. Patients with detectable neutralizing anti-Adagen® antibodies at screening evaluation

3. Severe thrombocytopenia (platelet count <50 x 10^9/L)

4. Current participation in other therapeutic protocols for ADA-deficient combined immunodeficiency

5. Current or prior participation in another clinical study with an investigational agent and/or use of an investigational drug in the 30 days before study entry

6. Known planned participation in a gene-therapy study for the planned duration of this study

7. Any condition that, in the opinion of the PI, makes the patient unsuitable for the study

8. Inability or unwillingness to administer Adagen® or EZN-2279 on a one-time-per-week regimen

9. Inability to comply with the study protocol

10. Female patients who are pregnant or lactating

11. Female patients who are breast-feeding

12. Female subjects of childbearing potential who are not using an FDA approved birth control method

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
2	University of California San Francisco	San Francisco	California	United States	94158
3	National Jewish Health	Denver	Colorado	United States	80206-2761
4	Albert Einstein College of Medicine	Bronx	New York	United States	10461
5	UBMD	Buffalo	New York	United States	14203
6	Penn State College of Medicine The Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Leadiant Biosciences, Inc.

Investigators

• Principal Investigator: Elie Haddad, MD, PhD, Université de Montréal

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 4, 2019
• Study Protocol - Aug 23, 2017

More Information

Publications

None provided.

• Responsible Party: Leadiant Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT01420627
• Other Study ID Numbers: STP-2279-002
• First Posted: Aug 19, 2011
• Last Update Posted: Apr 16, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes

Study Results

Participant Flow

Arm/Group Title	Adagen/EZN-2279
Arm/Group Description	Patients started on Adagen and crossed over to experimental EZN-2279 treatment
Period Title: Adagen Lead-in Period
STARTED	7
COMPLETED	7
NOT COMPLETED	0
Period Title: Adagen Lead-in Period
STARTED	7
COMPLETED	6
NOT COMPLETED	1
Period Title: Adagen Lead-in Period
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Adagen/EZN-2279
Arm/Group Description	Patients started on Adagen and crossed over to experimental EZN-2279 treatment after at least a 3 week Lead-in Period on Adagen EZN-2279: Weekly administration of EZN-2279 via IM injection Adagen
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.3 (9.52)
Sex: Female, Male (Count of Participants)
Female	2 28.6%
Male	5 71.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 42.9%
Not Hispanic or Latino	4 57.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 14.3%
White	4 57.1%
More than one race	0 0%
Unknown or Not Reported	2 28.6%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Description	Number of patients with total erythrocyte dAXP concentration from a trough blood sample <0.02 mmol/L
Time Frame	Baseline through Week T-21

Outcome Measure Data

Analysis Population Description

Completer

Arm/Group Title	EZN-2279
Arm/Group Description	Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
Measure Participants	6
Baseline	6 85.7%
Week T-1	6 85.7%
Week T-3	6 85.7%
Week T-5	5 71.4%
Week T-7	6 85.7%
Week T-8	6 85.7%
Week T-9	3 42.9%
Week T-10	5 71.4%
Week T-11	6 85.7%
Week T-13	6 85.7%
Week T-15	6 85.7%
Week T-17	6 85.7%
Week T-19	6 85.7%
Week T-21	6 85.7%

2. Secondary Outcome

Title	Safety Summary Data
Description	Summary of adverse events and serious adverse events
Time Frame	Through end of EZN-2279 study treatment, up to 203 weeks

Outcome Measure Data

Analysis Population Description

As-treated

Arm/Group Title	Adagen	EZN-2279
Arm/Group Description	Patients received Adagen during the Lead-in Period	Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
Measure Participants	7	7
Patients with treatment-emergent adverse events	6 85.7%	7 NaN
Mild TEAE	4 57.1%	1 NaN
Moderate TEAE	2 28.6%	3 NaN
Severe TEAE	0 0%	3 NaN
Treatment-related adverse event	1 14.3%	2 NaN
Mild related AE	1 14.3%	1 NaN
Moderate related AE	0 0%	0 NaN
Severe related AE	0 0%	1 NaN
Patients with any SAE	0 0%	4 NaN
Patients discontinued treatment due to AE	0 0%	1 NaN
Non-serious AEs	6 85.7%	7 NaN

3. Secondary Outcome

Title	Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Description	Trough ADA activity, mmol/h/L
Time Frame	From Baseline through Week T-21

Outcome Measure Data

Analysis Population Description

Completer

Arm/Group Title	EZN-2279 Treatment Period
Arm/Group Description	Patients who completed at least a 3-week Adagen Lead-in Period and entered the 21-week Treatment Period
Measure Participants	6
Baseline	15.7800
Week T-1	14.0950
Change from Baseline at Week T-1	-1.7450
Week T-3	23.3850
Change from Baseline at Week T-3	7.6500
Week T-5	28.5600
Change from Baseline at Week T-5	13.3800
Week T-7	34.8000
Change from Baseline at Week T-7	19.000
Week T-8	32.9300
Change from Baseline at Week T-8	18.7400
Week T-9	38.8750
Change from Baseline at Week T-9	24.6840
Week T-10	37.7000
Change from baseline at Week T-10	24.5000
Week T-11	36.4350
Change from Baseline at Week T-11	21.1950
Week T-13	36.1000
Change from Baseline at Week T-13	21.1150
Week T-15	35.7850
Change from Baseline at Week T-15	20.3950
Week T-17	31.1000
Change from Baseline at Week T-17	12.3500
Week T-19	32.4200
Change from Baseline at Week T-19	14.4300
Week T-21	30.1500
Change from Baseline at Week T-21	13.7500

4. Secondary Outcome

Title	Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Description	Trough ADA activity levels, mmol/h/L
Time Frame	Through end of EZN-2279 study treatment, up to 203 weeks

Outcome Measure Data

Analysis Population Description

Completer

Arm/Group Title	EZN-2279 Treatment Period
Arm/Group Description	Patients who completed at least a 3-week Adagen Lead-in Period and entered the 21-week Treatment Period
Measure Participants	6
Baseline	15.7800
Week 34	31.1000
Change from Baseline at Week 34	14.0350
Week 47	37.9000
Change from Baseline at Week 47	21.2600
Week 60	35.3100
Change from Baseline at Week 60	20.1300
Week 73	42.1900
Change from Baseline at Week 73	22.5900
Week 86	41.2000
Change from Baseline at Week 86	25.5600
Week 99	42.200
Change from Baseline at Week 99	26.5800
Week 112	31.6750
Change from Baseline at Week 112	10.4250
Week 125	39.2700
Change from Baseline at Week 125	21.1150
Week 138	46.0600
Change from Baseline at Week 138	26.4600
Week 151	36.6700
Change from Baseline at Week 151	17.070
Week 164	34.4500
Change from Baseline at Week 164	11.5500
Week 177	33.1300
Change from Baseline at Week 177	13.5300
Week 190	32.5000
Change from Baseline at Week 190	11.5800
Week 203	36.3300
Change from Baseline at Week 203	16.7300
End of Study/Early Discontinuation	39.7700
Change from Baseline at End of Study/Early Discont	22.3800

5. Secondary Outcome

Title	Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Description	Trough dAXP levels, mmol/L
Time Frame	From Baseline through Week T-21

Outcome Measure Data

Analysis Population Description

Completer

Arm/Group Title	EZN-2279 Treatment Period
Arm/Group Description	Patients who completed at least a 3-week Adagen Lead-in Period and entered the 21-week Treatment Period
Measure Participants	6
Baseline	0.0020
Week T-1	0.0020
Change from Baseline at Week T-1	0.0000
Week T-3	0.0020
Change from Baseline at Week T-3	0.0000
Week T-5	0.0020
Change from Baseline at Week T-5	0.0000
Week T-7	0.0020
Change from Baseline at Week T-7	0.0000
Week T-8	0.0020
Change from Baseline at Week T-8	0.0000
Week T-9	0.0020
Change from Baseline at Week T-9	0.0000
Week T-10	0.0020
Change from Baseline at Week T-10	0.0000
Week T-11	0.0020
Change from Baseline at Week T-11	0.0000
Week T-13	0.0020
Change from Baseline at Week T-13	0.0000
Week T-15	0.0020
Change from Baseline at Week T-15	0.0000
Week T-17	0.0020
Change from Baseline at Week T-17	0.0000
Week T-19	0.0020
Change from Baseline at Week T-19	0.0000
Week T-21	0.0020
Change from Baseline at Week T-21	0.0000

6. Secondary Outcome

Title	Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Description	Trough dAXP levels, mmol/L
Time Frame	Through end of EZN-2279 study treatment, up to 203 weeks

Outcome Measure Data

Analysis Population Description

Completer

Arm/Group Title	EZN-2279 Treatment Period
Arm/Group Description	Patients who completed at least a 3-week Adagen Lead-in Period and entered the 21-week Treatment Period
Measure Participants	6
Baseline	0.0020
Week 34	0.0020
Change from Baseline at Week 34	0.0000
Week 47	0.0020
Change from Baseline at Week 47	0.0000
Week 60	0.0020
Change from Baseline at Week 60	0.0000
Week 73	0.0020
Change from Baseline at Week 73	0.0000
Week 86	0.0020
Change from Baseline at Week 86	0.0000
Week 99	0.0020
Change from Baseline at Week 99	0.000
Week 112	0.0020
Change from Baseline at Week 112	0.0000
Week 125	0.0020
Change from Baseline at Week 125	0.0000
Week 138	0.0020
Change from Baseline at Week 138	0.0000
Week 151	0.0020
Change from Baseline at Week 151	0.0000
Week 164	0.0020
Change from Baseline at Week 164	0.0000
Week 177	0.0020
Change from Baseline at Week 177	0.0000
Week 190	0.0020
Change from Baseline at Week 190	0.0000
Week 203	0.0020
Change from Baseline at Week 203	0.0000
End of Study/Early Discontinuation	0.0020
Change from Baseline at End of Study/Early Discont	0.0000

7. Secondary Outcome

Title	Number of Patients With Infections and Hospitalizations
Description	Infections were documented clinically with signs and symptoms without microbiologic cultures or with positive viral or bacterial cultures
Time Frame	Through end of EZN-2279 study treatment, up to 203 weeks

Outcome Measure Data

Analysis Population Description

As-treated

Arm/Group Title	EZN-2279
Arm/Group Description	Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
Measure Participants	7
Patients with infection	5 71.4%
Patients with hospitalizations	3 42.9%

8. Secondary Outcome

Title	Duration of Hospitalization
Time Frame	Through end of EZN-2279 study treatment, up to 203 weeks

Outcome Measure Data

Analysis Population Description

As-treated population who were hospitalized

Arm/Group Title	EZN-2279
Arm/Group Description	Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
Measure Participants	3
Measure Number of hospitalizations (3 patients)	4
Mean (Standard Deviation) [Days]	5.0 (2.16)

9. Secondary Outcome

Title	Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Description	Number of patients with total erythrocyte dAXP concentration from a trough blood sample <0.02 mmol/L
Time Frame	From Week 34 to End of Study/Early Discontinuation, up to 203 weeks

Outcome Measure Data

Analysis Population Description

Completer

Arm/Group Title	EZN-2279 Treatment Period
Arm/Group Description	Patients who completed at least a 3-week Adagen Lead-in Period and entered the 21-week Treatment Period
Measure Participants	6
Baseline	6 85.7%
Week 34	6 85.7%
Week 47	6 85.7%
Week 60	3 42.9%
Week 73	5 71.4%
Week 86	5 71.4%
Week 99	5 71.4%
Week 112	4 57.1%
Week 125	4 57.1%
Week 138	3 42.9%
Week 151	3 42.9%
Week 164	3 42.9%
Week 177	3 42.9%
Week 190	3 42.9%
Week 203	3 42.9%
End of Study/Early Discontinuation	3 42.9%

Adverse Events

Time Frame	Through end of EZN-2279 study treatment, up to 203 weeks
Arm/Group Title	Adagen		EZN-2279
Arm/Group Description	Patients received Adagen during the Lead-in Period (at least 3 weeks)		Patients received EZN-2279 after crossing over from Adagen
All Cause Mortality
	Adagen		EZN-2279
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Adagen		EZN-2279
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		4/7 (57.1%)
General disorders
Injection site pain	0/7 (0%)		1/7 (14.3%)
Infections and infestations
Respiratory tract infection	0/7 (0%)		1/7 (14.3%)
Tooth abscess	0/7 (0%)		1/7 (14.3%)
Metabolism and nutrition disorders
Dehydration	0/7 (0%)		1/7 (14.3%)
Nervous system disorders
Vestibular migraine	0/7 (0%)		1/7 (14.3%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis	0/7 (0%)		1/7 (14.3%)
Surgical and medical procedures
Tooth extraction	0/7 (0%)		1/7 (14.3%)
Other (Not Including Serious) Adverse Events
	Adagen		EZN-2279
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		7/7 (100%)
Blood and lymphatic system disorders
Lymphadenopathy	1/7 (14.3%)		1/7 (14.3%)
Ear and labyrinth disorders
Deafness neurosensory	0/7 (0%)		1/7 (14.3%)
Ear disorder	0/7 (0%)		1/7 (14.3%)
Excessive cerumen production	0/7 (0%)		1/7 (14.3%)
Eye disorders
Conjunctivitis allergic	0/7 (0%)		1/7 (14.3%)
Gastrointestinal disorders
Vomiting	1/7 (14.3%)		3/7 (42.9%)
Diarrhoea	0/7 (0%)		2/7 (28.6%)
Nausea	0/7 (0%)		2/7 (28.6%)
Abdominal pain lower	0/7 (0%)		1/7 (14.3%)
Abdominal pain upper	0/7 (0%)		1/7 (14.3%)
Anogenital dysplasia	0/7 (0%)		1/7 (14.3%)
Colitis	0/7 (0%)		1/7 (14.3%)
Constipation	0/7 (0%)		1/7 (14.3%)
Dental caries	0/7 (0%)		1/7 (14.3%)
Haematochezia	0/7 (0%)		1/7 (14.3%)
Oral pain	0/7 (0%)		1/7 (14.3%)
Toothache	0/7 (0%)		1/7 (14.3%)
General disorders
Non-cardiac chest pain	0/7 (0%)		2/7 (28.6%)
Pyrexia	0/7 (0%)		2/7 (28.6%)
Asthenia	0/7 (0%)		1/7 (14.3%)
Chills	0/7 (0%)		1/7 (14.3%)
Fatigue	0/7 (0%)		1/7 (14.3%)
Gait disturbance	0/7 (0%)		1/7 (14.3%)
Injection site bruising	0/7 (0%)		1/7 (14.3%)
Injection site discomfort	0/7 (0%)		1/7 (14.3%)
Injection site haemorrhage	0/7 (0%)		1/7 (14.3%)
Injection site pain	0/7 (0%)		1/7 (14.3%)
Malaise	0/7 (0%)		1/7 (14.3%)
Nodule	0/7 (0%)		1/7 (14.3%)
Peripheral swelling	0/7 (0%)		1/7 (14.3%)
Infections and infestations
Upper respiratory tract infection	0/7 (0%)		2/7 (28.6%)
Alveolar osteitis	0/7 (0%)		1/7 (14.3%)
Candida infection	0/7 (0%)		1/7 (14.3%)
Conjunctivitis bacterial	0/7 (0%)		1/7 (14.3%)
Ear lobe infection	0/7 (0%)		1/7 (14.3%)
Fungal skin infection	0/7 (0%)		1/7 (14.3%)
Gastrointestinal infection	0/7 (0%)		1/7 (14.3%)
Genital infection fungal	0/7 (0%)		1/7 (14.3%)
Groin abscess	1/7 (14.3%)		1/7 (14.3%)
Haemophilus infection	0/7 (0%)		1/7 (14.3%)
Herpes zoster	0/7 (0%)		1/7 (14.3%)
Influenza	0/7 (0%)		1/7 (14.3%)
Oral candidiasis	0/7 (0%)		1/7 (14.3%)
Otitis externa	0/7 (0%)		1/7 (14.3%)
Respiratory tract infection	1/7 (14.3%)		1/7 (14.3%)
Stoma site infection	0/7 (0%)		1/7 (14.3%)
Subcutaneous abscess	0/7 (0%)		1/7 (14.3%)
Tooth abscess	0/7 (0%)		1/7 (14.3%)
Vulvovaginal mycotic infection	0/7 (0%)		1/7 (14.3%)
Epidermodysplasia verruciformis	1/7 (14.3%)		0/7 (0%)
Gastroenteritis	1/7 (14.3%)		0/7 (0%)
Injury, poisoning and procedural complications
Eye contusion	0/7 (0%)		1/7 (14.3%)
Fall	0/7 (0%)		1/7 (14.3%)
Skin laceration	0/7 (0%)		1/7 (14.3%)
Investigations
Blood immunoglobulin G increased	0/7 (0%)		1/7 (14.3%)
Immunoglobulins increased	0/7 (0%)		1/7 (14.3%)
Monoclonal immunoglobulin present	0/7 (0%)		1/7 (14.3%)
Crystal urine present	1/7 (14.3%)		0/7 (0%)
Full blood count abnormal	1/7 (14.3%)		0/7 (0%)
Metabolism and nutrition disorders
Dehydration	0/7 (0%)		1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/7 (0%)		1/7 (14.3%)
Axillary mass	0/7 (0%)		1/7 (14.3%)
Back pain	2/7 (28.6%)		0/7 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma	0/7 (0%)		1/7 (14.3%)
Skin papilloma	0/7 (0%)		1/7 (14.3%)
Nervous system disorders
Headache	0/7 (0%)		1/7 (14.3%)
Sciatica	0/7 (0%)		1/7 (14.3%)
Seizure	0/7 (0%)		1/7 (14.3%)
Vestibular migraine	0/7 (0%)		1/7 (14.3%)
Dizziness	1/7 (14.3%)		0/7 (0%)
Psychiatric disorders
Anxiety	0/7 (0%)		1/7 (14.3%)
Insomnia	0/7 (0%)		1/7 (14.3%)
Renal and urinary disorders
Nephrolithiasis	0/7 (0%)		1/7 (14.3%)
Reproductive system and breast disorders
Scrotal mass	0/7 (0%)		1/7 (14.3%)
Testicular pain	0/7 (0%)		1/7 (14.3%)
Respiratory, thoracic and mediastinal disorders
Cough	0/7 (0%)		3/7 (42.9%)
Haemoptysis	0/7 (0%)		2/7 (28.6%)
Oropharyngeal pain	0/7 (0%)		2/7 (28.6%)
Productive cough	0/7 (0%)		2/7 (28.6%)
Epistaxis	0/7 (0%)		1/7 (14.3%)
Nasal oedema	0/7 (0%)		1/7 (14.3%)
Pulmonary mass	0/7 (0%)		1/7 (14.3%)
Skin and subcutaneous tissue disorders
Alopecia	0/7 (0%)		1/7 (14.3%)
Dermatitis contact	0/7 (0%)		1/7 (14.3%)
Erythema	0/7 (0%)		1/7 (14.3%)
Pruritus	0/7 (0%)		1/7 (14.3%)
Skin lesion	0/7 (0%)		1/7 (14.3%)
Swelling face	0/7 (0%)		1/7 (14.3%)
Surgical and medical procedures
Tooth extraction	0/7 (0%)		1/7 (14.3%)
Vascular disorders
Superior vena cava stenosis	0/7 (0%)		1/7 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.