Study: NCT00676065

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 86 affected / 16534 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 59 affected / 16534 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 96 affected / 16534 at risk

Adverse event: Diseases of the blood and the bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 16534 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 50 affected / 16534 at risk

Adverse event: Psychiatric & neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 114 affected / 16534 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 19 affected / 16534 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 16534 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 198 affected / 16534 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 56 affected / 16534 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 248 affected / 16534 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 82 affected / 16534 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 206 affected / 16534 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 279 affected / 16534 at risk

Adverse event: Pregnancy, delivery & puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs that occurred within 3 months after stop of OC use, were attributed to the last hormonal contraceptive used by the women. Therefore, pregnancy related SAEs on OC cohorts do not necessarily reflect unwanted pregnancies during HC use
Frequency: 51 affected / 16534 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 337 affected / 16534 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 86 affected / 15428 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 72 affected / 15428 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 97 affected / 15428 at risk

Adverse event: Diseases of the blood and the bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 15428 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 74 affected / 15428 at risk

Adverse event: Psychiatric & neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 136 affected / 15428 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 24 affected / 15428 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 28 affected / 15428 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 226 affected / 15428 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 15428 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 265 affected / 15428 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 15428 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 233 affected / 15428 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 290 affected / 15428 at risk

Adverse event: Pregnancy, delivery & puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs that occurred within 3 months after stop of OC use, were attributed to the last hormonal contraceptive used by the women. Therefore, pregnancy related SAEs on OC cohorts do not necessarily reflect unwanted pregnancies during HC use
Frequency: 62 affected / 15428 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 358 affected / 15428 at risk

Adverse event: Infectious diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 171 affected / 26341 at risk

Adverse event: Neoplasms, malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 124 affected / 26341 at risk

Adverse event: Neoplasms, benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 179 affected / 26341 at risk

Adverse event: Diseases of the blood and the bloodforming organs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 26341 at risk

Adverse event: Endocrine diseases
Serious: yes
Organ System: Endocrine disorders
Frequency: 96 affected / 26341 at risk

Adverse event: Psychiatric & neurological disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 274 affected / 26341 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 40 affected / 26341 at risk

Adverse event: Ear
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 53 affected / 26341 at risk

Adverse event: Cardiovascular system
Serious: yes
Organ System: Cardiac disorders
Frequency: 425 affected / 26341 at risk

Adverse event: Respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 128 affected / 26341 at risk

Adverse event: Digestive system
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 503 affected / 26341 at risk

Adverse event: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 200 affected / 26341 at risk

Adverse event: Muscoskeletal system & connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 403 affected / 26341 at risk

Adverse event: Genitourinary system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 572 affected / 26341 at risk

Adverse event: Pregnancy, delivery & puerperium
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs that occurred within 3 months after stop of OC use, were attributed to the last hormonal contraceptive used by the women. Therefore, pregnancy related SAEs on OC cohorts do not necessarily reflect unwanted pregnancies during HC use
Frequency: 99 affected / 26341 at risk

Adverse event: Injury, poisoning, accidents, etc.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 651 affected / 26341 at risk