Trial Outcomes & Findings for A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients (NCT NCT01093521)

Last Updated: 2022-11-29

Results Overview

To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF. To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF. Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28

Results posted on

2022-11-29

Participant Flow

Subjects were recruited in the Adult cystic fibrosis clinics at 3 centers (the University of Washington, University of Iowa, John's Hopkins University) from the second quarter 2010 and closed February 1, 2012. The study had two dosing cohorts. Cohort 1 completed enrollment in February, 2011. Cohort 2 completed enrollment on February 1, 2012.

We employed no run-in period. No subjects withdrew after randomization.

Participant milestones

Participant milestones
Measure	IV Gallium (Ganite®) Infusion Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Gallium (Ganite®) Infusion n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day
Age, Continuous	32.8 years STANDARD_DEVIATION 9.5 • n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	19 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants
Forced expiratory volume in one second (FEV1) (in liters)	2.25 liters n=99 Participants
Forced vital capacity (FVC)(in liters)	3.60 liters n=99 Participants
Mean Pseudomonas aeruginosa quantitative sputum culture (CFU's/gr of sputum)	116.7 Million CFU/gr of sputum n=99 Participants

PRIMARY outcome

Timeframe: Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=9 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day n=11 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)	503 ug*hr/mL Standard Deviation 98	537 ug*hr/mL Standard Deviation 153

PRIMARY outcome

Timeframe: 56 days from starting dose

Population: ITT

Safety as measured by serous adverse events

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Number of Serious Adverse Events	0 Serious Adverse Events	—

PRIMARY outcome

Timeframe: 6 days from starting dose

Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Number of Events When Study Drug Infusion Was Stopped Early	0 Number of times study drug interupted	—

SECONDARY outcome

Timeframe: 8 days

Population: ITT

Change in spirometry as measured by FEV1 in liters from baseline to day 8

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in Spirometry From Baseline to Day 8	0.13 liters Standard Deviation 0.18	—

SECONDARY outcome

Timeframe: 15 days from starting dose

Change in FEV1 in liters from baseline to day 15

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in Lung Function From Baseline to Day 15	0.13 liters Standard Deviation 0.17	—

SECONDARY outcome

Timeframe: 28 days from starting dose

Change in lung function as measured by FEV1 in liters from baseline to day 28

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in Spirometry From Baseline to Day 28	0.10 liters Standard Deviation 0.14	—

SECONDARY outcome

Timeframe: 56 days from starting dose

Population: all those subjects enrolled after the amendment to add a day 56 (ITT)

Change in lung function as measured by FEV1 in liters from baseline to day 56

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=11 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in Spirometry From Baseline to Day 56	0.12 liters Standard Deviation 0.19	—

SECONDARY outcome

Timeframe: 8 days from starting dose

Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=20 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in Spirometry as Measured by FVC From Baseline to Day 8	0.16 liters Standard Deviation 0.20	—

SECONDARY outcome

Timeframe: 8 days from starting dose

Population: All available specimens

Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=19 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in P. Aeruginosa Density From Baseline to Day 8	21.1 colony counts in millions per gm sputum Standard Deviation 297.5	—

SECONDARY outcome

Timeframe: 15 days from starting dose

Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=19 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in Sputum P. Aeruginosa Density From Baseline to Day 15	-5.5 colony counts in millions per gm sputum Standard Deviation 217.9	—

SECONDARY outcome

Timeframe: 56 days from starting dose

Population: All available specimens

Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56

Outcome measures

Outcome measures
Measure	IV Gallium (Ganite®) Infusion 100 mg/m2/Day n=5 Participants Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day	IV Gallium (Ganite®) Infusion 200 mg/m2/Day Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day
Change in P. Aeruginosa Density From Baseline to Day 56	-76.0 colony counts in millions per gm sputum Standard Deviation 58.3	—

Adverse Events

IV Gallium (Ganite®) Infusion

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IV Gallium (Ganite®) Infusion n=20 participants at risk Five day continuous IV Gallium (Ganite®)infusion IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day
Blood and lymphatic system disorders Lymphadenopathy	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Congenital, familial and genetic disorders Cystic fibrosis lung	15.0% 3/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Ear and labyrinth disorders External ear inflammation	10.0% 2/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Gastrointestinal disorders Abdominal distension	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Gastrointestinal disorders Abdominal pain	10.0% 2/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Gastrointestinal disorders Gastrointestinal reflux disease	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Gastrointestinal disorders Stomach discomfort	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Gastrointestinal disorders vomiting	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
General disorders fatigue	20.0% 4/20 • Number of events 4 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
General disorders Peripheral edema	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
General disorders pyrexia	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Infections and infestations urinary tract infection	5.0% 1/20 • Number of events 5 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Injury, poisoning and procedural complications infusion site bruising	15.0% 3/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Injury, poisoning and procedural complications infusion site hematoma	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Injury, poisoning and procedural complications infusion site pain	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Injury, poisoning and procedural complications infusion site swelling	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Investigations Blood glucose increased	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Musculoskeletal and connective tissue disorders Gout	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Musculoskeletal and connective tissue disorders Muscle spasms	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Musculoskeletal and connective tissue disorders neck stiffness	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Nervous system disorders headache	45.0% 9/20 • Number of events 16 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Nervous system disorders Migraine	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paresthesia	5.0% 1/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Renal and urinary disorders albuminuria	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Renal and urinary disorders Haematuria	10.0% 2/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Renal and urinary disorders Pyuria	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Reproductive system and breast disorders Pelvic pain	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders cough	20.0% 4/20 • Number of events 4 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders crackles lung	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 2/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Haemoptysis	25.0% 5/20 • Number of events 5 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Nasal congestion	15.0% 3/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Non-cardiac chest pain	15.0% 3/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Productive cough	15.0% 3/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Rhinitis	10.0% 2/20 • Number of events 2 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders sinus congestion	15.0% 3/20 • Number of events 4 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Sinus disorder	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Sputum discolored	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Throat irritation	15.0% 3/20 • Number of events 3 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Respiratory, thoracic and mediastinal disorders Voice alteration	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1 • 56 days At study visits, all body systems were assessed for adverse events. Serious adverse events were assessed at all study visits and participants were told to inform their research team of any serious adverse events occurring between study visits.

Additional Information

Christopher H. Goss, MD MSc

University of Washington

Phone: 206-543-3166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place