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 @ 7:08 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
NCT ID:
NCT03229057
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse Event data was collected for 7 months.
Study:
NCT03229057
Study Brief:
Comparing the Effects of Oral Contraceptive Pills Versus Metformin
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| OCP + Metformin | The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. OCP + Metformin: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned. | 0 | None | 3 | 80 | 78 | 80 | View |
| OCP + Placebo | The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (in order to induce menses). Placebo pills will be administered to individuals randomized to OCP only in order to maintain study blinding. OCP + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned. | 0 | None | 2 | 79 | 71 | 79 | View |
| Metformin + Placebo | Metformin will be initiated in a step-up fashion on cycle day 1-3 of spontaneously or induced menses. Extended release pills will be utilized as they are associated with fewer gastrointestinal side effects. Subjects will begin with one tablet of metformin every night for 5 days, eventually building up to 4 tablets every night, with the maximum dose of metformin being 2000 mg. Placebo pills will be administered to individuals randomized to metformin only in order to maintain study blinding. Metformin + Placebo: This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned. | 0 | None | 3 | 81 | 76 | 81 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Surgical Intervention | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Medical intervention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain/Cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vaginal Bleeding/Spotting | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Dysmenorrhea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Breast Symptoms | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache/Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mood Swings/Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Joint/muscle pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Upper Respiratory Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| COVID infection/symptoms after exposure | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |