Adverse Events Module

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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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:38 PM
NCT ID: NCT00290251
Description: Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.
Frequency Threshold: 0
Time Frame: 120 - 132 days
Study: NCT00290251
Study Brief: Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ulipristal Acetate- 10 mg Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles. 0 None 0 14 14 14 View
Placebo Women received placebo capsules for 90 - 102 days or three menstrual cycles. 0 None 0 14 12 14 View
Pre-Ulipristal Acetate 20 mg Women charted symptoms for one menstrual cycle before entering ulipristal acetate 20 mg group 0 None 0 14 10 14 View
Pre-Ulipristal Acetate- 10 mg Women charted symptoms for one menstrual cycle before entering ulipristal acetate 10 mg group 0 None 0 14 13 14 View
Pre-Placebo Women charted symptoms for one menstrual cycle before entering placebo group 0 None 0 14 10 14 View
Ulipristal Acetate -20mg Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles. 0 None 0 14 11 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Calf or Thigh pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
blood clots with menses SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Lower extremity edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
constipaton NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Non-menses Vaginal Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT General disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetitie SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal cramps SYSTEMATIC_ASSESSMENT General disorders None View
Mood changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bloating SYSTEMATIC_ASSESSMENT General disorders None View
Leg swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depersonalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
blurry vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
weight gain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hair loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
cold feet NON_SYSTEMATIC_ASSESSMENT General disorders None View
galactorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
food cravings NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
breast engorgement NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
disrupted sleep NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View