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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
NCT ID:
NCT00511433
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00511433
Study Brief:
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles. | None | None | 1 | 32 | 30 | 32 | View |
| DRSP-EE | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles. | None | None | 0 | 16 | 15 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis perforated | None | Gastrointestinal disorders | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weight decreased | None | Investigations | MedDRA (10.1) | View |
| Weight increased | None | Investigations | MedDRA (10.1) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Dizziness | None | Nervous system disorders | MedDRA (10.1) | View |
| Headache | None | Nervous system disorders | MedDRA (10.1) | View |
| Affect lability | None | Psychiatric disorders | MedDRA (10.1) | View |
| Depressed mood | None | Psychiatric disorders | MedDRA (10.1) | View |
| Dysuria | None | Renal and urinary disorders | MedDRA (10.1) | View |
| Micturition urgency | None | Renal and urinary disorders | MedDRA (10.1) | View |
| Breast enlargement | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Breast pain | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Breast tenderness | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Dysmenorrhoea | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Pelvic pain | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Vaginal discharge | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Vaginal odour | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Acne | None | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Hirsutism | None | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Pain of skin | None | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Skin odour abnormal | None | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Hot flush | None | Vascular disorders | MedDRA (10.1) | View |
| Sunburn | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Abdominal pain lower | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Food poisoning | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Toothache | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Fatigue | None | General disorders | MedDRA (10.1) | View |
| Hangover | None | General disorders | MedDRA (10.1) | View |
| Malaise | None | General disorders | MedDRA (10.1) | View |
| Hypersensitivity | None | Immune system disorders | MedDRA (10.1) | View |
| Cystitis | None | Infections and infestations | MedDRA (10.1) | View |
| Gastroenteritis | None | Infections and infestations | MedDRA (10.1) | View |
| Influenza | None | Infections and infestations | MedDRA (10.1) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (10.1) | View |
| Pyelonephritis | None | Infections and infestations | MedDRA (10.1) | View |
| Vaginal candidiasis | None | Infections and infestations | MedDRA (10.1) | View |
| Foreign body in eye | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Palpitations | None | Cardiac disorders | MedDRA (10.1) | View |
| Conjunctivitis | None | Eye disorders | MedDRA (10.1) | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (10.1) | View |