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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Day 1 Protocol | Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. | None | None | 2 | 65 | 9 | 65 | View |
| Day 7 Protocol | Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. | None | None | 4 | 65 | 14 | 65 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Anal fissure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site burning | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Ovarian Hyperstimulation syndrome | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Metrorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Adnexa uterin pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Oestradiol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |