A Randomized Phase 2 Study to Evaluate Efficacy and Safety of AR36 for Prevention of Acute Mountain Sickness

Total26 (61.9) [81]30 (71.4) [60]24 (55.8) [70]Ear and labyrinth disorders1 (2.4) [1]01 (2.3) [1] Motion sickness, tinnitusEye disorders1 (2.4) [1]00 Eye discomfortGastrointestinal disorders14 (33.3) [21]15 (35.7) [18]10 (23.3) [18] Abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, abdominal pain lower, diarrhea, dry mouth, dyspepsia, dysphagia, eructation, flatulence, frequent bowel movements, gastrointestinal pain, gastroesophageal reflux disease, nausea, vomitingGeneral/administration site conditions6 (14.3) [6]4 (9.5) [4]6 (14.0) [8] Chest discomfort, chest pain, edema (peripheral), fatigue, feeling hot, hangover, pain, pyrexiaInfections and infestations3 (7.1) [3]2 (4.8) [2]2 (4.7) [2] Nasopharyngitis, respiratory tract infectionInvestigations3 (7.1) [4]3 (7.1) [3]2 (4.7) [2] Abnormal QRS axis, blood pressure increase, hepatic enzyme increase, low voltage electrocardiogramMetabolic and nutritional disorders01 (2.4) [1]0 Decreased appetiteMusculoskeletal and connective tissue disorders3 (7.1) [5]2 (4.8) [3]8 (18.6) [11] Arthralgia, flank and neck pain, joint swelling, muscle spasms, myalgia, pain in extremity, temporomandibular joint syndromeNervous system disorders15 (35.7) [22]12 (28.6) [14]10 (23.3) [12] Cluster headache, dizziness, dysgeusia, head discomfort, headache, hypoesthesia, lethargy, paresthesia, parosmia and poor sleep quality, presyncope, somnolence, syncope, tension headachePsychiatric disorders3 (7.1) [3]02 (4.7) [3] Abnormal dreams, anxiety, insomnia and restlessness, irritabilityReproductive disorders3 (7.1) [3]1 (2.4) [2]3 (7.0) [3] Breast pain and tenderness, dysmenorrhea, priapism, vaginal hemorrhageRespiratory, thoracic, and mediastinal disorders9 (21.4) [12]8 (19.0) [9]3 (7.0) [7] Acute pulmonary edema, cough and allergic cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, painful respiration and respiratory tract congestion, paranasal sinus discomfort, pharyngeal paresthesia, throat irritationSkin and subcutaneous disorders02 (4.8) [2]1 (2.3) [1] Night sweats, rash, and photosensitivity reactionSurgical and medical procedures001 (2.3) [1] Endodontic procedureVascular disorders02 (4.8) [2]1 (2.3) [1] Flushing, and hot flush, hypertension

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