Study: NCT00521586

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 551 at risk

Adverse event: Abdominal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 551 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 551 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 551 at risk

Adverse event: Abnormal sensation in eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 551 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Anorectal polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 551 at risk

Adverse event: Aggravated generalized joint pain: any
Serious: no
Organ System: General disorders
Frequency: 62 affected / 292 at risk

Adverse event: Aggravated generalized muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 109 affected / 314 at risk

Adverse event: Any systemic event
Serious: no
Organ System: General disorders
Frequency: 417 affected / 484 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Chills: any
Serious: no
Organ System: General disorders
Frequency: 96 affected / 306 at risk

Adverse event: Decreased appetite: any
Serious: no
Organ System: General disorders
Frequency: 95 affected / 315 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Fatigue: any
Serious: no
Organ System: General disorders
Frequency: 226 affected / 389 at risk

Adverse event: Fever: 38.0 to 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 261 at risk

Adverse event: Fever: 38.5 to 39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 262 at risk

Adverse event: Fever: 39.0 to 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Headache: any
Serious: no
Organ System: General disorders
Frequency: 263 affected / 399 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 551 at risk

Adverse event: Injection site movement impairment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: New joint pain: any
Serious: no
Organ System: General disorders
Frequency: 102 affected / 309 at risk

Adverse event: New muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 252 affected / 385 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Rash: any
Serious: no
Organ System: General disorders
Frequency: 35 affected / 278 at risk

Adverse event: Vomiting: any
Serious: no
Organ System: General disorders
Frequency: 14 affected / 266 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 551 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 551 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 551 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 551 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Post procedural infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 551 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 551 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 551 at risk

Adverse event: International normalised ratio decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 551 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 551 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 551 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 551 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Mobility decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 551 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Cervicobrachial syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 551 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 551 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 551 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 551 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 551 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 551 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Any local reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 420 affected / 474 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 551 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Limitation of arm movement: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 113 affected / 317 at risk

Adverse event: Limitation of arm movement: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 101 affected / 310 at risk

Adverse event: Limitation of arm movement: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 269 at risk

Adverse event: Limitation of arm movement: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 266 at risk

Adverse event: Pain: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 407 affected / 469 at risk

Adverse event: Pain: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 380 affected / 459 at risk

Adverse event: Pain: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 127 affected / 324 at risk

Adverse event: Pain: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 267 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 282 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 281 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 265 at risk

Adverse event: Redness: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 53 affected / 288 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 288 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 263 at risk

Adverse event: Swelling: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 551 at risk

Adverse event: Acute pain at injection site (Mild)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 551 at risk

Adverse event: Acute Pain at injection site (Any)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 551 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 538 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 538 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 538 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 538 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 538 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 538 at risk

Adverse event: Aggravated generalized joint pain: any
Serious: no
Organ System: General disorders
Frequency: 41 affected / 264 at risk

Adverse event: Aggravated generalized muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 50 affected / 268 at risk

Adverse event: Any systemic event
Serious: no
Organ System: General disorders
Frequency: 248 affected / 381 at risk

Adverse event: Chills: any
Serious: no
Organ System: General disorders
Frequency: 56 affected / 273 at risk

Adverse event: Decreased appetite: any
Serious: no
Organ System: General disorders
Frequency: 55 affected / 270 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 538 at risk

Adverse event: Fatigue: any
Serious: no
Organ System: General disorders
Frequency: 138 affected / 316 at risk

Adverse event: Fever: > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Fever: 38.0 to 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 238 at risk

Adverse event: Fever: 38.5 to 39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 239 at risk

Adverse event: Fever: 39.0 to 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 236 at risk

Adverse event: Headache: any
Serious: no
Organ System: General disorders
Frequency: 161 affected / 334 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: New joint pain: any
Serious: no
Organ System: General disorders
Frequency: 55 affected / 268 at risk

Adverse event: New muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 82 affected / 288 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Rash: any
Serious: no
Organ System: General disorders
Frequency: 15 affected / 246 at risk

Adverse event: Vomiting: any
Serious: no
Organ System: General disorders
Frequency: 17 affected / 247 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 538 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 538 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 538 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 538 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 538 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 538 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 538 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 538 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 538 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 538 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 538 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 538 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 538 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 538 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 538 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 538 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 538 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 538 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 538 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 538 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Any local reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 105 affected / 300 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Limitation of arm movement: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 248 at risk

Adverse event: Limitation of arm movement: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 248 at risk

Adverse event: Limitation of arm movement: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 236 at risk

Adverse event: Pain: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 294 at risk

Adverse event: Pain: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 89 affected / 290 at risk

Adverse event: Pain: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 243 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 238 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 238 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 242 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 242 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 236 at risk

Adverse event: Acute pain at injection site (Mild)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 538 at risk

Adverse event: Acute Pain at injection site (Any)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 538 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 538 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 538 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 538 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 538 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Colonic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 538 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 538 at risk

Adverse event: Leiomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 538 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 538 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 538 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 538 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 538 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 538 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 538 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 538 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 538 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 538 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 538 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 538 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Intervertebral disc degeneration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Systemic lupus erythematosus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 538 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 538 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 538 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 538 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 538 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 538 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 538 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 536 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 536 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 536 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 536 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 536 at risk

Adverse event: Thyroid cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 536 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 536 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 536 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 364 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 364 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 364 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 364 at risk

Adverse event: Aggravated generalized joint pain: any
Serious: no
Organ System: General disorders
Frequency: 38 affected / 218 at risk

Adverse event: Aggravated generalized muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 72 affected / 241 at risk

Adverse event: Any systemic event
Serious: no
Organ System: General disorders
Frequency: 221 affected / 307 at risk

Adverse event: Chills: any
Serious: no
Organ System: General disorders
Frequency: 53 affected / 229 at risk

Adverse event: Decreased appetite: any
Serious: no
Organ System: General disorders
Frequency: 46 affected / 226 at risk

Adverse event: Fatigue: any
Serious: no
Organ System: General disorders
Frequency: 115 affected / 263 at risk

Adverse event: Fever: > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Fever: 38.0 to 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Fever: 38.5 to 39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 206 at risk

Adverse event: Headache: any
Serious: no
Organ System: General disorders
Frequency: 120 affected / 256 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 364 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 364 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 364 at risk

Adverse event: New joint pain: any
Serious: no
Organ System: General disorders
Frequency: 42 affected / 219 at risk

Adverse event: New muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 127 affected / 266 at risk

Adverse event: Rash: any
Serious: no
Organ System: General disorders
Frequency: 16 affected / 209 at risk

Adverse event: Vessel puncture site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 364 at risk

Adverse event: Vomiting: any
Serious: no
Organ System: General disorders
Frequency: 7 affected / 206 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 364 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 364 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 364 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 364 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 364 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 364 at risk

Adverse event: Any local reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 256 affected / 315 at risk

Adverse event: Limitation of arm movement: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 233 at risk

Adverse event: Limitation of arm movement: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 233 at risk

Adverse event: Limitation of arm movement: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 208 at risk

Adverse event: Limitation of arm movement: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 206 at risk

Adverse event: Pain: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 248 affected / 313 at risk

Adverse event: Pain: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 227 affected / 297 at risk

Adverse event: Pain: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 81 affected / 248 at risk

Adverse event: Pain: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 206 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 216 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 215 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 210 at risk

Adverse event: Redness: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 205 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 224 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 223 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 211 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 364 at risk

Adverse event: Acute pain at injection site (Mild)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 364 at risk

Adverse event: Acute Pain at injection site (Moderate)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 364 at risk

Adverse event: Acute Pain at injection site (Any)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 364 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 364 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 364 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 364 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 560 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 560 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 560 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 560 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Anaemia macrocytic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 560 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 560 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 560 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 560 at risk

Adverse event: Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 560 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 560 at risk

Adverse event: Abdominal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 560 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 560 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 560 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 560 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 560 at risk

Adverse event: Rectal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 560 at risk

Adverse event: Aggravated generalized joint pain: any
Serious: no
Organ System: General disorders
Frequency: 51 affected / 284 at risk

Adverse event: Aggravated generalized muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 71 affected / 294 at risk

Adverse event: Any systemic event
Serious: no
Organ System: General disorders
Frequency: 326 affected / 430 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 560 at risk

Adverse event: Chills: any
Serious: no
Organ System: General disorders
Frequency: 61 affected / 291 at risk

Adverse event: Decreased appetite: any
Serious: no
Organ System: General disorders
Frequency: 68 affected / 301 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 560 at risk

Adverse event: Fatigue: any
Serious: no
Organ System: General disorders
Frequency: 188 affected / 359 at risk

Adverse event: Fever: > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 257 at risk

Adverse event: Fever: 38.0 to 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 259 at risk

Adverse event: Headache: any
Serious: no
Organ System: General disorders
Frequency: 216 affected / 382 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 560 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 560 at risk

Adverse event: New joint pain: any
Serious: no
Organ System: General disorders
Frequency: 73 affected / 296 at risk

Adverse event: New muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 123 affected / 326 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 560 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 560 at risk

Adverse event: Rash: any
Serious: no
Organ System: General disorders
Frequency: 13 affected / 264 at risk

Adverse event: Vomiting: any
Serious: no
Organ System: General disorders
Frequency: 9 affected / 262 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 560 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 560 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 560 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 560 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 560 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 560 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 560 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 560 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 560 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 560 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 560 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 560 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 560 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 560 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 560 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 560 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 560 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 560 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 560 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 560 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 560 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 560 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 560 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 560 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 560 at risk

Adverse event: Any local reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 128 affected / 325 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Limitation of arm movement: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 270 at risk

Adverse event: Limitation of arm movement: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 268 at risk

Adverse event: Limitation of arm movement: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 259 at risk

Adverse event: Limitation of arm movement: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 258 at risk

Adverse event: Onychoclasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Pain: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 119 affected / 321 at risk

Adverse event: Pain: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 112 affected / 318 at risk

Adverse event: Pain: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 261 at risk

Adverse event: Pain: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 258 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 560 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 560 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 263 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 262 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 258 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 263 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 263 at risk

Adverse event: Acute pain at injection site (Mild)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 560 at risk

Adverse event: Acute Pain at injection site (Any)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 560 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 543 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 543 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 543 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 543 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 543 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 543 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 543 at risk

Adverse event: Aggravated generalized joint pain: any
Serious: no
Organ System: General disorders
Frequency: 67 affected / 282 at risk

Adverse event: Aggravated generalized muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 112 affected / 305 at risk

Adverse event: Any systemic event
Serious: no
Organ System: General disorders
Frequency: 326 affected / 425 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 543 at risk

Adverse event: Chills: any
Serious: no
Organ System: General disorders
Frequency: 68 affected / 276 at risk

Adverse event: Decreased appetite: any
Serious: no
Organ System: General disorders
Frequency: 72 affected / 279 at risk

Adverse event: Fatigue: any
Serious: no
Organ System: General disorders
Frequency: 175 affected / 338 at risk

Adverse event: Fever: 38.0 to 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 241 at risk

Adverse event: Fever: 38.5 to 39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 2 affected / 240 at risk

Adverse event: Fever: 39.0 to 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 240 at risk

Adverse event: Headache: any
Serious: no
Organ System: General disorders
Frequency: 172 affected / 338 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 543 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 543 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 543 at risk

Adverse event: New joint pain: any
Serious: no
Organ System: General disorders
Frequency: 78 affected / 285 at risk

Adverse event: New muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 207 affected / 350 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 543 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 543 at risk

Adverse event: Rash: any
Serious: no
Organ System: General disorders
Frequency: 24 affected / 252 at risk

Adverse event: Vomiting: any
Serious: no
Organ System: General disorders
Frequency: 15 affected / 247 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 543 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 543 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 543 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 543 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 543 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 543 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Intervertebral disc degeneration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Morton's neuralgia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 543 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 543 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 543 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 543 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 543 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 543 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Any local reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 388 affected / 456 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 543 at risk

Adverse event: Limitation of arm movement: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 135 affected / 318 at risk

Adverse event: Limitation of arm movement: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 130 affected / 316 at risk

Adverse event: Limitation of arm movement: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 248 at risk

Adverse event: Limitation of arm movement: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 244 at risk

Adverse event: Pain: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 383 affected / 453 at risk

Adverse event: Pain: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 354 affected / 431 at risk

Adverse event: Pain: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 131 affected / 319 at risk

Adverse event: Pain: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 248 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 257 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 255 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 248 at risk

Adverse event: Redness: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 242 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 265 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 260 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 249 at risk

Adverse event: Swelling: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Acute pain at injection site (Mild)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 543 at risk

Adverse event: Acute Pain at injection site (Any)
Serious: no
Organ System: General disorders
Frequency: 35 affected / 543 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 543 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 543 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 543 at risk

Adverse event: Coeliac disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 543 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 543 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 543 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 543 at risk

Adverse event: Impaired fasting glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 543 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 543 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 543 at risk

Adverse event: Morton's neuralgia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 543 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 543 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Menopause
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 543 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 543 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 542 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 542 at risk

Adverse event: Bone cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 542 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 542 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 363 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 363 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 363 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 363 at risk

Adverse event: Aggravated generalized joint pain: any
Serious: no
Organ System: General disorders
Frequency: 39 affected / 214 at risk

Adverse event: Aggravated generalized muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 61 affected / 223 at risk

Adverse event: Any systemic event
Serious: no
Organ System: General disorders
Frequency: 218 affected / 290 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Chills: any
Serious: no
Organ System: General disorders
Frequency: 48 affected / 217 at risk

Adverse event: Decreased appetite: any
Serious: no
Organ System: General disorders
Frequency: 50 affected / 227 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Fatigue: any
Serious: no
Organ System: General disorders
Frequency: 115 affected / 251 at risk

Adverse event: Fever: > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 204 at risk

Adverse event: Fever: 38.0 to 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 5 affected / 206 at risk

Adverse event: Fever: 38.5 to 39.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 204 at risk

Adverse event: Headache: any
Serious: no
Organ System: General disorders
Frequency: 127 affected / 248 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: New joint pain: any
Serious: no
Organ System: General disorders
Frequency: 48 affected / 219 at risk

Adverse event: New muscle pain: any
Serious: no
Organ System: General disorders
Frequency: 129 affected / 253 at risk

Adverse event: Rash: any
Serious: no
Organ System: General disorders
Frequency: 29 affected / 210 at risk

Adverse event: Vomiting: any
Serious: no
Organ System: General disorders
Frequency: 15 affected / 207 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 363 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 363 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 363 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 363 at risk

Adverse event: Any local reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 248 affected / 308 at risk

Adverse event: Limitation of arm movement: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 224 at risk

Adverse event: Limitation of arm movement: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 219 at risk

Adverse event: Limitation of arm movement: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 206 at risk

Adverse event: Limitation of arm movement: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 206 at risk

Adverse event: Pain: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 243 affected / 306 at risk

Adverse event: Pain: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 224 affected / 299 at risk

Adverse event: Pain: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 82 affected / 235 at risk

Adverse event: Pain: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 205 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 363 at risk

Adverse event: Redness: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 215 at risk

Adverse event: Redness: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 212 at risk

Adverse event: Redness: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 211 at risk

Adverse event: Redness: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 202 at risk

Adverse event: Swelling: Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 216 at risk

Adverse event: Swelling: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 214 at risk

Adverse event: Swelling: Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 208 at risk

Adverse event: Swelling: Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 203 at risk

Adverse event: Acute pain at injection site (Mild)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 363 at risk

Adverse event: Acute Pain at injection site (Any)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 363 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 363 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 363 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 363 at risk