Study: NCT01868646

Adverse event: Brain stem stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 76 at risk

Adverse event: Diabetic edematous maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 76 at risk

Adverse event: Edema of the upper eyelid of the right eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 76 at risk

Adverse event: Periodic pain in the left hypochondrium
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Periodic dull aching pain in the right hypochondrium
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Chronic parenchymal pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Chronic hemorrhagic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Chronic hemorrhagic gastritis, associated with Helicobacter, exacerbation
Frequency: 1 affected / 76 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Edema of the lower lip
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: esurience
Serious: no
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Complaints about general fatigue, a feeling of total severity and swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Fatty liver hepatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 76 at risk

Adverse event: bilateral lacunar tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: acute respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 76 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 76 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pain in the knee joints
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: melosalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pain in the lumbar spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: cervical vertebral osteochondrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Diabetic distal sensory lower limb polyneuropathy, worsening
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Increased numbness in the fingers, feets
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Tingling in the region of the heart that occurs after excitement on a background of a stressful situ
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 76 at risk

Adverse event: Phobia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 76 at risk

Adverse event: skin itch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: A papular rash in the area of the forearms, hands, right knee joint
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Urticaria on the extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 72 at risk

Adverse event: Hypochromic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Duodenitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Tongue discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Drawing pains in the right hypochondrium
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: chronic colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Chronic parenchymal pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Fatty liver hepatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 72 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: acute respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 72 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Erysipelas of the right lower leg
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Fracture of radial head to the right
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 72 at risk

Adverse event: Fracture of terminal phalanx of 5th toe of left foot
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 72 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 72 at risk

Adverse event: rapid pulse
Serious: no
Organ System: Investigations
Frequency: 1 affected / 72 at risk

Adverse event: hypercholesterinemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Dyslipidemia, worsening
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pain in the lumbar spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Twitching of the right eye against a background of stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk