Trial Outcomes & Findings for Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer (NCT NCT02688608)

NCT ID: NCT02688608

Last Updated: 2022-02-10

Results Overview

Overall response (OR) represents those participants that collectively achieve either complete response (CR) or partial response (PR) within 18 months, as defined below per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * 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 * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the cumulative number of participants receiving at least one dose of study treatment, that achieve either a CR or PR with 6 months, a number without dispersion.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: up to 18 months.
• Results posted on: 2022-02-10

Participant Flow

Participant milestones

Measure	Pembrolizumab 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Pembrolizumab 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Overall Study Lost to Follow-up	1

Baseline Characteristics

Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer

Baseline characteristics by cohort

Measure	Pembrolizumab n=6 Participants 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 18 months.

Population: Response assessment data was not obtained for all participants.

Overall response (OR) represents those participants that collectively achieve either complete response (CR) or partial response (PR) within 18 months, as defined below per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

• 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
• Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
• Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the cumulative number of participants receiving at least one dose of study treatment, that achieve either a CR or PR with 6 months, a number without dispersion.

Outcome measures

Measure	Pembrolizumab n=5 Participants 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Overall Response (OR) Complete Response (CR)	0 Participants
Overall Response (OR) Partial Response (PR)	3 Participants
Overall Response (OR) Overall Response (OR)	3 Participants
Overall Response (OR) Stable disease (SD)	1 Participants
Overall Response (OR) Progressive disease (PD)	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Survival data was not available for all participants.

Progression-free survival (PFS) means to remain alive without disease progression. Progressive disease is defined as a 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s). The outcome is reported as the number of participants who received at least one dose of study treatment and remained alive without progression at 2 years after the beginning of treatment, a number without dispersion.

Outcome measures

Measure	Pembrolizumab n=5 Participants 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Progression-free Survival (PFS)	0 Participants

SECONDARY outcome

Timeframe: 2 years

Safety of the study treatment pembrolizumab is based on the number of adverse effects caused by pembrolizumab, referred to as related adverse events or toxicities. Reported adverse events (related) will be serious as defined by the Code of Federal Regulations at 21CFR§312.32, or non-serious. The outcome is reported as the number of non-serious and serious adverse events that occurred with the nominal study period (35 cycles or 2 years) that were reported as possibly, probably, or definitely related to pembrolizumab, a number without dispersion.

Outcome measures

Measure	Pembrolizumab n=6 Participants 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Adverse Events Associated With Pembrolizumab Non-serious Adverse Events	35 related adverse events
Adverse Events Associated With Pembrolizumab Serious Adverse Events	1 related adverse events

SECONDARY outcome

Timeframe: 2 years

Population: Survival data was not available for all participants.

Overall survival (OS) means to remain alive without consideration of treatment response status.

The outcome is reported as the number of participants who received at least one dose of study treatment and were known to remain alive at 2 years after the beginning of treatment, a number without dispersion. Subjects who become lost-to-follow-up before the 2-year assessment are not included.

Outcome measures

Measure	Pembrolizumab n=5 Participants 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Overall Survival (OS)	0 Participants

Adverse Events

Pembrolizumab

Serious events: 6 serious events

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Measure	Pembrolizumab n=6 participants at risk 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Mucositis, oral	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm, other - disease progression	83.3% 5/6 • Number of events 5 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Nervous system disorders Parietal mass, right front	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia, aspiration	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Rash	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Skin and subcutaneous tissue disorders Skin irritation, pain at GI tube site	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.

Other adverse events

Measure	Pembrolizumab n=6 participants at risk 200 milligrams of Pembrolizumab will be given intravenously every 3 weeks. Pembrolizumab: 200 mg IV once every 3 weeks
Blood and lymphatic system disorders Anemia	66.7% 4/6 • Number of events 4 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Blood and lymphatic system disorders Hypocalcemia	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Cardiac disorders Palpitations	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Ear and labyrinth disorders Ear pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Eye disorders Blurred Vision	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Eye disorders Double vision	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Heartburn	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Intermittent Abdominal pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Loss of sensation, lip	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Mucositis	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Oral Lesions	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Pruritus (itching), lips	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Gastrointestinal disorders Trouble swallowing	66.7% 4/6 • Number of events 4 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Appetite change	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Chills	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Cold intolerance	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Fatigue	100.0% 6/6 • Number of events 15 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Focal weakness	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders General Weakness	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Leg swelling	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
General disorders Redness	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Infections and infestations Oral Lesions	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Infections and infestations Sinusitis	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Injury, poisoning and procedural complications Bruising	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Investigations ALK phosphate increase	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Investigations ALT/AST increase	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Investigations Elevated creatinine	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Investigations Platelet count decreased	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Investigations Weight loss	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Metabolism and nutrition disorders Diaphoresis (excessive sweating)	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Arthritis (joint inflamation)	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Back Pain	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders General Weakness	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Joint pain	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Pain	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Pain, low back	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Musculoskeletal and connective tissue disorders Pain, neck	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Nervous system disorders Sensory Change	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Nervous system disorders Speech change	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Renal and urinary disorders Polydipsia	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Renal and urinary disorders Urinary urgency	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 4/6 • Number of events 4 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Cough, dry	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Cough, productive	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Cough, wet	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis (nosebleed)	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Hemoptysis	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Intermittent cough	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Seasonal allergies	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Shortness of breath	83.3% 5/6 • Number of events 5 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Shortness of breath, recumbent (orthopnea)	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Sore throat	50.0% 3/6 • Number of events 3 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Sputum production	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Skin and subcutaneous tissue disorders Night sweats	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Skin and subcutaneous tissue disorders Pruritus (itching)	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Skin and subcutaneous tissue disorders Pruritus (itching), dry skin	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Vascular disorders Hot flashes	33.3% 2/6 • Number of events 2 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Vascular disorders Hypertension	100.0% 6/6 • Number of events 18 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Vascular disorders Orthopnea	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.
Vascular disorders Pulmonary Embolism	16.7% 1/6 • Number of events 1 • 2 years Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.

Additional Information

Saad A Khan, MD

Stanford Medicine at Stanford University

Phone: 650-507-5624

Email: Saad.A.Khan@stanford.edu

Results disclosure agreements

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