A Trial to Assess the Safety, Tolerability, and Pharmacok... | NCT02474589

Name	Class
Biomedical Advanced Research and Development Authority	FED

Label	Type	Description	Intervention Names
Active	Active Comparator	600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects	Drug: tecovirimat
Placebo	Placebo Comparator	matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
tecovirimat	Drug	Study is based on Animal Regulatory Rule	Active	ST-246

Measure	Description	Time Frame
To Determine the Number of Participants With Adverse Events	To determine the safety and tolerability of oral tecovirimat	45 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 80 years old, inclusive
Available for clinical follow-up for the duration of the study
Able and willing to give informed consent
In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for the last 2 years
Able to comply with dietary requirements throughout the study drug dosing period
Adequate venous access for those individuals participating in PK testing
PE and laboratory results without clinically significant findings within the 14 days before receipt of study drug
Agree not to drink alcohol from the beginning of the Screening Period through the completion of the Day 28 Follow up Visit
Agree not to use any nicotine products, including electronic vapor cigarettes, nicotine patches or nicotine gum for at least 30 days before the Day 1 Visit and through completion of the Day 15 Dosing complete Visit
Agree not to consume caffeine during all study visits, including overnight stays if participating in PK subset
Agree not to receive any immunizations/vaccinations
Agree not to take herbal products
Able and willing to refrain from taking any prescriptions and nonprescription medications with exceptions
For women of childbearing potential, negative serum and urine pregnancy testing
If male, agree not to donate sperm
Meet 1 of the following criteria: The subject or their partner has undergone surgical sterilization; the subject is postmenopausal; the subject agrees to be abstinent; the subject agrees to consistently use a method of approved birth control.

Exclusion Criteria:

Pregnant or breast-feeding or planning pregnancy
Have a history of any clinically significant conditions
Have any limitation of activity related to cardiac disease
Have a bleeding disorder diagnosed by a doctor, or a history of significant bruising or bleeding with intramuscular injections or blood draws
Currently using certain medications
Have a malignancy that is active or a treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study
Have a history of seizure
Have a clinically significant blood dyscrasia
Have a history of drug allergy that contraindicates participation in the trial
Have a medical, psychiatric, or social condition or any occupational reason, or other responsibility that in the judgment of the investigator would render the subject unable to comply with the protocol
Have an inability to swallow medication
Have a clinically significant abnormal ECG
Have participated in a clinical trials within 30 days of study entry or planning to participate in any experimental treatment study during the study period
Have a history or current drug or alcohol abuse
Have received immunizations/vaccines
Have a current clinically significant acute bacterial, fungal, or mycobacterial infection requiring administration of systemic antibiotics
Have known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection with the exception of clinically significant dermal infections
Have known hepatitis B or C infection, or positive test result
Have known HIV infection or AIDS or a positive test for HIV
Have a current clinically significant viral infection
Have known clinically significant chronic viral infection
have received treatment with greater than 20 mg prednisone or equivalent dose or any immunosuppressant or immunomodulary medication
Have abnormal laboratory testing during screening
Have a greater than or equal than 20% risk of suffering a major cardiovascular event
Have been previously enrolled in this or any clinical trial involving tecovirimat

Name	Affiliation	Role
Dennis Hruby, Ph.D.	SIGA Technologies, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Clinical Research, Inc.		Mobile	Alabama	36608	United States
Paradigm Research

PubMed Identifier	Type	Citation	Retractions
29972742	Derived	Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, Lovejoy C, Meara I, Long P, Hruby DE. Oral Tecovirimat for the Treatment of Smallpox. N Engl J Med. 2018 Jul 5;379(1):44-53. doi: 10.1056/NEJMoa1705688.

ID	Title	Description
FG000	Active	600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule
FG001	Placebo

ID	Title	Description
BG000	Active	600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule
BG001	Placebo	matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000359 BG00190 BG002449

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Active	600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule			1	359	134	359
EG001	Placebo	matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply			0	90	30	90

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG000104 events61 affected359 at risk EG00119 events13 affected90 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG00029 events20 affected359 at risk EG0015 events5 affected90 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG00013 events11 affected359 at risk EG0014 events3 affected90 at risk
Dizziness	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0009 events9 affected359 at risk EG0013 events3 affected90 at risk
Fatigue	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0005 events5 affected359 at risk EG0014 events4 affected90 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG00010 events9 affected359 at risk EG0010 events0 affected90 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0005 events5 affected359 at risk EG0012 events2 affected90 at risk
Somnolence	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0012 events2 affected90 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0012 events2 affected90 at risk
Oropharyngeal pain	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0012 events2 affected90 at risk
Disturbance in Attention	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Migraine	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0004 events4 affected359 at risk EG0010 events0 affected90 at risk
Dysgeusia	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Syncope	Nervous system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0007 events6 affected359 at risk EG0010 events0 affected90 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0005 events5 affected359 at risk EG0010 events0 affected90 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0003 events3 affected359 at risk EG0011 events1 affected90 at risk
Abdominal Distention	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected90 at risk
Abdominal DIscomfort	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Chapped Lips	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Epigastric Discomfort	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Eructation	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Hypoaesthesia Oral	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Paraesthesia Oral	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events1 affected359 at risk EG0010 events0 affected90 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Uvulitis	Gastrointestinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0006 events6 affected359 at risk EG0011 events1 affected90 at risk
Acute Sinusitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Bacterial Vaginosis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Bronchitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Fungal Infection	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Influenza	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Kidney Infection	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Sinusitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Tooth Abscess	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Viral Infection	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Folliculitis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Pyrexia	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0004 events4 affected359 at risk EG0010 events0 affected90 at risk
Pain	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0003 events3 affected359 at risk EG0010 events0 affected90 at risk
Chills	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Asthenia	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Malaise	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Oedema Peripheral	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Thirst	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Peripheral Swelling	General disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0004 events3 affected359 at risk EG0010 events0 affected90 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0003 events2 affected359 at risk EG0011 events1 affected90 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected90 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Palpable Purpura	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Pruritis Generalized	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected90 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Skin Hypertrophy	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0011 events1 affected90 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0011 events1 affected90 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected90 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Pain in Jaw	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events1 affected359 at risk EG0010 events0 affected90 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 18.0 or later	Systematic Assessment	EG0004 events4 affected359 at risk EG0010 events0 affected90 at risk
Ligament Sprain	Musculoskeletal and connective tissue disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Depression	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Nervousness	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Dysphoria	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events1 affected359 at risk EG0011 events1 affected90 at risk
Irritability	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Panic Attack	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Libido Increased	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Nighmare	Psychiatric disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0012 events2 affected90 at risk
Pumonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected90 at risk
Sputum Retention	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Vasomotor Rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0011 events1 affected90 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Blood Pressure Systolic Increased	Investigations	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Electroencephalogram Abnormal	Investigations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Haematocrit Decreased	Investigations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Haemoglobin Decreased	Investigations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Heart Rate Increased	Investigations	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 18.0 or later	Systematic Assessment	EG0002 events2 affected359 at risk EG0010 events0 affected90 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Hearing Impaired	Ear and labyrinth disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Eye Irritation	Eye disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Menstruation Irregular	Reproductive system and breast disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Peripheral Coldness	Vascular disorders	MedDRA 18.0 or later	Systematic Assessment	EG0001 events1 affected359 at risk EG0010 events0 affected90 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0 or later	Systematic Assessment	EG0000 events0 affected359 at risk EG0011 events1 affected90 at risk

ID	Term
D011213	Poxviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections