Study: NCT01228318

Adverse event: Hospitalization due to pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization due to abdominal pain
Serious: yes
Organ System: General disorders
Notes: Participant was hospitalized with complaints of abdominal pain and was discharged after being observed for 24 hours.
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization due to community acquired pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization due to neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Participant was admitted with multiple diagnoses that were unrelated to study treatment
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization due to gastro esphageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant was admitted due to chest pain and abnormal electrocardiogram; cardiac tests were normal and gastro esophageal reflux disease was diagnosed
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization due to brochitis and otitis externa
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 34 at risk

Adverse event: Nasal/sinus drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 34 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 26 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 34 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: General disorders
Frequency: 27 affected / 34 at risk

Adverse event: Rash (head, shoulder, feet)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 34 at risk

Adverse event: Decreased libido
Serious: no
Organ System: General disorders
Frequency: 24 affected / 34 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 34 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 21 affected / 34 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 20 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 34 at risk

Adverse event: Myalgias
Serious: no
Organ System: General disorders
Frequency: 20 affected / 34 at risk

Adverse event: Arthralgias
Serious: no
Organ System: General disorders
Frequency: 18 affected / 34 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 34 at risk

Adverse event: Flulike symptoms
Serious: no
Organ System: General disorders
Frequency: 18 affected / 34 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 34 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 17 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 17 affected / 34 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 34 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 17 affected / 34 at risk

Adverse event: Amnesia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 34 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 34 at risk

Adverse event: Motor weakness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 34 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 34 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 34 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 34 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 34 at risk

Adverse event: Photophobia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 34 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 34 at risk

Adverse event: Odynophagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Kaposi sarcoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 34 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 34 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 34 at risk

Adverse event: Generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Left eye twitching
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain from shingles
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Groin pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 34 at risk

Adverse event: Muscle cramps (hands, feet, legs)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Intermittent nose bleed
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain in right ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Proctalgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Ankle tenderness/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Flank pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Bitter mouth taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Bone pain in left hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dark spots
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Decreased hearing/ear stopped up
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Easily distracted
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Entire body heat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk

Adverse event: Itchy/watery eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Facial acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Hotflashes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Numbness (hands, legs, body)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Neck pain/stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pain in right knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Right wrist pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Stomach feels tight
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Welts when skin scratched
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hospitalization due to community acquired pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant admitted to psychiatric unit due to homicidal intentions against family member. This event is considered unrelated to study treatment.
Frequency: 1 affected / 29 at risk

Adverse event: Hospitalization related to Graves' Disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hospitalization due to sub-acute cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 29 at risk

Adverse event: Nasal/sinus drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 29 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Numbness/tingling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 29 at risk

Adverse event: Rash (head, shoulder, feet)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 29 at risk

Adverse event: Decreased libido
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 29 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 29 at risk

Adverse event: Myalgias
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Arthralgias
Serious: no
Organ System: General disorders
Frequency: 17 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 29 at risk

Adverse event: Flulike symptoms
Serious: no
Organ System: General disorders
Frequency: 13 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 29 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 13 affected / 29 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 12 affected / 29 at risk

Adverse event: Amnesia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 29 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 29 at risk

Adverse event: Motor weakness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 29 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Photophobia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 29 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 29 at risk

Adverse event: Odynophagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 29 at risk

Adverse event: Generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Left eye twitching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain from shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Muscle cramps (hands, feet, legs)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain in right ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ankle tenderness/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Boil left buttock
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Bruising easily
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bump inside mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Burning in chest with excertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Itchy/watery eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: General body aches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hearing voices
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Herpes outbreak
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Knee swollen
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Lower left leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Left sided weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Numbness (hands, legs, body)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Balance disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neck pain/stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Rash left forehead
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Right shoulder discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Right facial swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Right side weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Scalp pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Seeing spots
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Testicular pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk