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 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
NCT ID:
NCT00280735
Description:
None
Frequency Threshold:
0
Time Frame:
30 days following cessation of treatment
Study:
NCT00280735
Study Brief:
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Single Arm Trial | adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) docetaxel: 75 mg/m² intravenously, once, every 3 weeks | None | None | 19 | 72 | 63 | 72 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac ischemia/infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Version 3 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Version 3 | View |
| Supraventricular and nodal arrhythmia - Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Version 3 | View |
| Supraventricular and nodal arrhythmia - Supraventricular arrhythmia not otherwise specified (NOS) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Version 3 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Version 3 | View |
| Infections, Other (Specify, _Neutropenic sepsis) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE Version 3 | View |
| Syncope (fainting) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 3 | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |
| Hemoglobin | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Version 3 | View |
| Leukocytes (total WBC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| Neutrophils/granulocytes (ANC/AGC) | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| Platelets | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Version 3 | View |
| Cardiac ischemia/infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE Version 3 | View |
| Constitutional Symptoms - Other (Specify- Weakness) | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 3 | View |
| Fatigue (asthenia, lethargy, malaise) | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 3 | View |
| Allergic reaction/hypersensitivity (including drug fever) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | NCI CTCAE Version 3 | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 3 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Version 3 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE Version 3 | View |
| Hair loss/alopecia (scalp or body) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3 | View |
| Rash/desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Heartburn/dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Mucositis/stomatitis (functional/symptomatic) - Oral cavity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Taste alteration (dysgeusia) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 3 | View |
| Ulcer, GI - Stomach | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE Version 3 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE Version 3 | View |
| Edema: limb | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 3 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Version 3 | View |
| Renal/Genitourinary - Other (Specify, __UTI) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE Version 3 | View |
| Albumin, serum-low (hypoalbuminemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE Version 3 | View |
| Calcium, serum-low (hypocalcemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Glucose, serum-high (hyperglycemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Magnesium, serum-low (hypomagnesemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Potassium, serum-high (hyperkalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Potassium, serum-low (hypokalemia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Sodium, serum-low (hyponatremia) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE Version 3 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 3 | View |
| Mood alteration - Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE Version 3 | View |
| Neuropathy: motor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 3 | View |
| Neuropathy: sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 3 | View |
| Syncope (fainting) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE Version 3 | View |
| Dry eye syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE Version 3 | View |
| Pain - Back | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | View |
| Pain - bone | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | View |
| Pain -Chest | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 3 | View |
| Pain - Joint | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | View |
| Pain - Muscle | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3 | View |
| Pain - Other (Specify, _Thoracotomy site) | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE Version 3 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |
| Dyspnea (shortness of breath) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |
| Hiccoughs (hiccups, singultus) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |
| Pulmonary/Upper Respiratory - Other (Specify, _paranasal sinus reaction; runny nose/chills) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 3 | View |