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 @ 12:01 PM
Ignite Modification Date:
2025-12-25 @ 11:57 AM
NCT ID:
NCT00274261
Description:
The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Frequency Threshold:
2
Time Frame:
None
Study:
NCT00274261
Study Brief:
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Conceptrol | Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel. | None | None | 12 | 560 | 434 | 560 | View |
| C31G | C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel | None | None | 10 | 836 | 617 | 836 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | None | View |
| Palpitations | None | Cardiac disorders | None | View |
| Diabetic ketoacidosis | None | Endocrine disorders | None | View |
| Crohn's Disease | None | Gastrointestinal disorders | None | View |
| Food poisoning | None | Gastrointestinal disorders | None | View |
| Gastroenteritis escherichia coli | None | Gastrointestinal disorders | None | View |
| Gastroenteritis viral | None | Gastrointestinal disorders | None | View |
| Gastrointestinal pain | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Bile duct stone | None | Hepatobiliary disorders | None | View |
| Cholelithiasis | None | Hepatobiliary disorders | None | View |
| Hypersensitivity | None | Immune system disorders | None | View |
| Infection | None | Infections and infestations | None | View |
| Laceration | None | Injury, poisoning and procedural complications | None | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | None | View |
| Joint dislocation | None | Musculoskeletal and connective tissue disorders | None | View |
| Dermoid Cyst | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Ovarian Cyst Ruptured | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Uterine leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Meningitis viral | None | Nervous system disorders | None | View |
| Ectopic pregnancy | None | Pregnancy, puerperium and perinatal conditions | None | View |
| Acute stress disorder | None | Psychiatric disorders | None | View |
| Depression | None | Psychiatric disorders | None | View |
| Kidney Infection | None | Renal and urinary disorders | None | View |
| Stress incontinence | None | Renal and urinary disorders | None | View |
| Menorrhagia | None | Reproductive system and breast disorders | None | View |
| Pelvic inflammatory disease | None | Reproductive system and breast disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vaginal mycosis | None | Infections and infestations | None | View |
| Menstrual cycle prolonged | None | Reproductive system and breast disorders | None | View |
| Dysmenorrhoea | None | Reproductive system and breast disorders | None | View |
| Oligomenorrhoea | None | Reproductive system and breast disorders | None | View |
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Vaginal burning sensation | None | Reproductive system and breast disorders | None | View |
| Vaginal odor | None | Reproductive system and breast disorders | None | View |
| Nasopharygitis | None | Infections and infestations | None | View |
| Vaginitis bacterial | None | Infections and infestations | None | View |
| Headache | None | Nervous system disorders | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Metrorrhagia | None | Reproductive system and breast disorders | None | View |
| Menstruation irregular | None | Reproductive system and breast disorders | None | View |
| Influenza | None | Infections and infestations | None | View |
| Genital pruritus female | None | Reproductive system and breast disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Smear cervix abnormal | None | Investigations | None | View |
| Pharyngolaryngeal pain | None | Gastrointestinal disorders | None | View |
| Toothache | None | Gastrointestinal disorders | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Sinusitis | None | Infections and infestations | None | View |
| Vulvovaginal discomfort | None | Reproductive system and breast disorders | None | View |