Study: NCT00335257

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 7264 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 26 affected / 7264 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 7264 at risk

Adverse event: Diseases of the blood and blood-forming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 7264 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 7264 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 53 affected / 7264 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 7264 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 7264 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 7264 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 7264 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 7264 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 7264 at risk

Adverse event: Musculoskeletal system and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 7264 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 93 affected / 7264 at risk

Adverse event: Pregnancy, delivery and puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use.
Frequency: 22 affected / 7264 at risk

Adverse event: Injury, poisoning, accidents, etc
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 85 affected / 7264 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 5605 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 5605 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 5605 at risk

Adverse event: Diseases of the blood and blood-forming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 5605 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 8 affected / 5605 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 32 affected / 5605 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 5605 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 5605 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 51 affected / 5605 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 5605 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 116 affected / 5605 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 5605 at risk

Adverse event: Musculoskeletal system and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 5605 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 74 affected / 5605 at risk

Adverse event: Pregnancy, delivery and puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use.
Frequency: 32 affected / 5605 at risk

Adverse event: Injury, poisoning, accidents, etc
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 66 affected / 5605 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 137 affected / 39316 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 119 affected / 39316 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 36 affected / 39316 at risk

Adverse event: Diseases of the blood and blood-forming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 39316 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 47 affected / 39316 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 226 affected / 39316 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 14 affected / 39316 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 39316 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 278 affected / 39316 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 183 affected / 39316 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 553 affected / 39316 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 39316 at risk

Adverse event: Musculoskeletal system and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 39316 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 471 affected / 39316 at risk

Adverse event: Pregnancy, delivery and puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use.
Frequency: 151 affected / 39316 at risk

Adverse event: Injury, poisoning, accidents, etc
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 383 affected / 39316 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 4070 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 4070 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4070 at risk

Adverse event: Diseases of the blood and blood-forming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 4070 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 4070 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 23 affected / 4070 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4070 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 4070 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 4070 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 4070 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4070 at risk

Adverse event: Musculoskeletal system and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 4070 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 44 affected / 4070 at risk

Adverse event: Pregnancy, delivery and puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use.
Frequency: 9 affected / 4070 at risk

Adverse event: Injury, poisoning, accidents, etc
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 4070 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 68 affected / 28854 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 57 affected / 28854 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 28854 at risk

Adverse event: Diseases of the blood and blood-forming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 28854 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 26 affected / 28854 at risk

Adverse event: Psychiatric and neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 109 affected / 28854 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 7 affected / 28854 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 28854 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 98 affected / 28854 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 77 affected / 28854 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 259 affected / 28854 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 28854 at risk

Adverse event: Musculoskeletal system and connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 28854 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 253 affected / 28854 at risk

Adverse event: Pregnancy, delivery and puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use.
Frequency: 571 affected / 28854 at risk

Adverse event: Injury, poisoning, accidents, etc
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 136 affected / 28854 at risk