Study: NCT00556439

Adverse event: Ocular/visual - other
Serious: yes
Organ System: Eye disorders
Notes: Branch retinal artery occlusion - 1 event, Transient vision loss - presumed due to GCA - 1 event
Frequency: 2 affected / 20 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Intraoperative-injury - other
Serious: yes
Organ System: Surgical and medical procedures
Notes: Total knee replacement
Frequency: 1 affected / 20 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Notes: Post-operative deep venous thrombosis
Frequency: 1 affected / 20 at risk

Adverse event: Gastrointestinal - other
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diarrhea/dehydration
Frequency: 1 affected / 20 at risk

Adverse event: Dermatology /Skin - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Herpes zoster - 1 event - abatacept, Squamous cell carcinoma - 1 event - placebo
Frequency: 1 affected / 20 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Notes: Diverticulitis
Frequency: 1 affected / 20 at risk

Adverse event: Renal/genitourinary - other
Serious: yes
Organ System: Renal and urinary disorders
Notes: Endometrial carcinoma - 1 event Transitional cell carcinoma - 1 event
Frequency: 2 affected / 20 at risk

Adverse event: Blood and bone marrow - other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cardiac arrhythmia - other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Endocrine - other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gastrointestinal - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Metabolic/laboratory - other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Musculoskeletal/Soft tissue - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ocular/Visual - other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain - other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary/Upper respiratory - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Renal/Genitourinary - other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dermatology /Skin - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Herpes zoster - 1 event - abatacept, Squamous cell carcinoma - 1 event - placebo
Frequency: 1 affected / 21 at risk

Adverse event: Metabolic/laboratory - other
Serious: yes
Organ System: Investigations
Notes: Hyperglycemia
Frequency: 1 affected / 21 at risk

Adverse event: Bone: spine-scoliosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spinal surgery
Frequency: 1 affected / 21 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 1 affected / 21 at risk

Adverse event: Pain - other
Serious: yes
Organ System: General disorders
Notes: Narcotic withdrawal
Frequency: 1 affected / 21 at risk

Adverse event: Pulmonary/Upper respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea - 1 event, COPD - 1 event
Frequency: 2 affected / 21 at risk

Adverse event: Urinary electrolyte wasting
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urine electrolyte disturbance
Frequency: 1 affected / 21 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Endocrine - other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypothyroid
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastrointestinal - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 21 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Arthritis non-septic
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Joint - function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Musculoskeletal/Soft tissue - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 21 at risk

Adverse event: Ocular/Visual - other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Ulcer - GI
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Duodenal ulcer
Frequency: 1 affected / 11 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Notes: Possible pyelonephritis - 1 event - abatacept, Skin site infection post thrombectomy - 1 event - abatacept, Pyelonephritis - 1 event - placebo, Epiglottitis - 1 event - placebo
Frequency: 2 affected / 11 at risk

Adverse event: Pain - other
Serious: yes
Organ System: General disorders
Notes: Non cardiac chest pain - 6 events in 1 participant - abatacept, Headache due to Migraine - 1 event - abatacept, Chest pain unclear etiology - 1 event - placebo
Frequency: 2 affected / 11 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Notes: Arterial thrombosis following angioplasty
Frequency: 1 affected / 11 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Notes: Elective aortic surgery
Frequency: 1 affected / 11 at risk

Adverse event: Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cardiac general - other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dermatology/skin - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Endocrine - other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 11 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Albumin, serum - low
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Glucose, serum - high
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Glucose, serum - low
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ocular/visual - other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Gastrointestinal - other
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ischemic colitis
Frequency: 1 affected / 15 at risk

Adverse event: Hemorrhage - GI
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ischemic colitis - 1 event, Rectal bleeding - 1 event
Frequency: 2 affected / 15 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Notes: Possible pyelonephritis - 1 event - abatacept, Skin site infection post thrombectomy - 1 event - abatacept, Pyelonephritis - 1 event - placebo, Epiglottitis - 1 event - placebo
Frequency: 2 affected / 15 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Notes: Appendicitis - 1 event, Nausea/vomiting/diarrhea due to possible infection - 1 event
Frequency: 2 affected / 15 at risk

Adverse event: Pain - other
Serious: yes
Organ System: General disorders
Notes: Non cardiac chest pain - 6 events in 1 participant - abatacept, Headache due to Migraine - 1 event - abatacept, Chest pain unclear etiology - 1 event - placebo
Frequency: 1 affected / 15 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea/dysphagia due to GERD
Frequency: 1 affected / 15 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cardiac general - other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Dermatology/skin - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 15 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Calcium, serum - low
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Glucose, serum - low
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Metabolic/laboratory - other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Sodium, serum - low
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Neurology - other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain - other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vascular - other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk