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 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
NCT ID:
NCT00477633
Description:
None
Frequency Threshold:
2
Time Frame:
21 Jun 2007 thru 23 Jan 2009
Study:
NCT00477633
Study Brief:
Study of Safety and Efficacy of an Oral Contraceptive
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Norethindrone/Ethinyl Estradiol Tablets | 1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo | None | None | 20 | 1677 | 1179 | 1677 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mengitis, Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Major Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Multiple Fractures | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Cholescystectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Intervertebral disc operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Cervical Dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Diarrhea Hemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Colitis Ischemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Cervical Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Vaginitis Bacterial | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Vulvovaginal Mycotic Infection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Laboratory Test Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Smear Cervix Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Fungal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |