Study: NCT00214903

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 12 affected / 10043 at risk

Adverse event: Neoplasms, malignant and benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 91 affected / 10043 at risk

Adverse event: Diseases of the blood and bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 1 affected / 10043 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 11 affected / 10043 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 50 affected / 10043 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 13 affected / 10043 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 14 affected / 10043 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 135 affected / 10043 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 33 affected / 10043 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 90 affected / 10043 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 7 affected / 10043 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 117 affected / 10043 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This adverse event term also includes renal and urinary disorders. Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 40 affected / 10043 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 93 affected / 10043 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 28 affected / 13384 at risk

Adverse event: Neoplasms, malignant and benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 248 affected / 13384 at risk

Adverse event: Diseases of the blood and bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 7 affected / 13384 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 36 affected / 13384 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 112 affected / 13384 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 32 affected / 13384 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 32 affected / 13384 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 542 affected / 13384 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 78 affected / 13384 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 237 affected / 13384 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 24 affected / 13384 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 285 affected / 13384 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This adverse event term also includes renal and urinary disorders. Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 111 affected / 13384 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 226 affected / 13384 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 8 affected / 4113 at risk

Adverse event: Neoplasms, malignant and benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 62 affected / 4113 at risk

Adverse event: Diseases of the blood and bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 2 affected / 4113 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 8 affected / 4113 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 33 affected / 4113 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 12 affected / 4113 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 9 affected / 4113 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 155 affected / 4113 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 27 affected / 4113 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 69 affected / 4113 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 5 affected / 4113 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 85 affected / 4113 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This adverse event term also includes renal and urinary disorders. Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 29 affected / 4113 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 72 affected / 4113 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 9 affected / 3057 at risk

Adverse event: Neoplasms, malignant and benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 58 affected / 3057 at risk

Adverse event: Diseases of the blood and bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 1 affected / 3057 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 8 affected / 3057 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 32 affected / 3057 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 10 affected / 3057 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 7 affected / 3057 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 130 affected / 3057 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 22 affected / 3057 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 68 affected / 3057 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 5 affected / 3057 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 70 affected / 3057 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This adverse event term also includes renal and urinary disorders. Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 24 affected / 3057 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.
Frequency: 64 affected / 3057 at risk