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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
NCT ID:
NCT00184093
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Study:
NCT00184093
Study Brief:
Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Gemcitabine Weekly x 6 Wks With Concurrent External Radiation | Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation | 0 | None | 10 | 35 | 33 | 35 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Rectal or perirectal pain (proctalgia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Vaginal bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (2.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain or cramping | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Arthralgia (joint pain) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Auditory/Hearing-Other (not specified) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Constitutional Symptoms-Other (not specified) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Diarrhea patients without colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dizziness/lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Dysuria (painful urination) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fatigue (lethargy, malaise, asthenia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Hematuria (in the absence of vaginal bleeding) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Hot flashes/flushes | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (2.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Infection without neutropenia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Inner ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Melena/GI bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Middle ear/hearing | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Mood alteration-anxiety, agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (2.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain-Other (specify, pelvic) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pigmentation changes (e.g., vitiligo) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Radiation Dermatitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (2.0) | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rectal bleeding/hematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Rectal or perirectal pain (proctalgia) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Rigors, chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Stomatitis/pharyngitis (ora/pharyngeal mucositis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | View |
| Vaginal bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (2.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |