Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
NCT ID:
NCT00266032
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00266032
Study Brief:
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300) | 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected. | None | None | 7 | 209 | 116 | 209 | View |
| Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300) | 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | None | None | 19 | 642 | 310 | 642 | View |
| Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300) | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected. | None | None | 3 | 216 | 121 | 216 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Vulval abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Perineal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Ligament rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Bladder neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Cervix carcinoma stage 0 | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| Pelvic peritoneal adhesions | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.1 | View |
| Nasal polyps | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gynaecological chlamydia infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Postoperative thrombosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Focal nodular hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Calculus urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.1 | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.1 | View |
| Rash generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Venous insufficiency | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Vulvovaginal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |