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 @ 5:16 PM
Ignite Modification Date:
2025-12-25 @ 2:53 PM
NCT ID:
NCT01413750
Description:
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold:
0
Time Frame:
Adverse events collected over a period of 2 years and 4 months
Study:
NCT01413750
Study Brief:
Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I: Dose Level 1 | Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days. Paclitaxel: Given IV Carboplatin: Given IV Vorinostat: Given PO Laboratory Biomarker Analysis: Correlative studies | None | None | 3 | 6 | 6 | 6 | View |
| Phase I: Dose Level 2 | Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days. Paclitaxel: Given IV Carboplatin: Given IV Vorinostat: Given PO Laboratory Biomarker Analysis: Correlative studies | None | None | 3 | 6 | 6 | 6 | View |
| Phase II: Vorinostat | Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days. Paclitaxel: Given IV Carboplatin: Given IV Voninostat: Given PO Laboratory Biomarker Analysis: Correlative studies | None | None | 3 | 4 | 4 | 4 | View |
| Phase II: Placebo | Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days. Paclitaxel: Given IV Carboplatin: Given IV Placebo: Given PO Laboratory Biomarker Analysis: Correlative studies | None | None | 5 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra12.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Esophageal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Sudden death NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra12.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra12.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra12.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra12.0 | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra12.0 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra12.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra12.0 | View |
| Blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | meddra12.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Gastrointestinal disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Mucositis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Stomach pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | meddra12.0 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra12.0 | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra12.0 | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra12.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Cardiac troponin I increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Cholesterol high | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| INR increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Lymphocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | meddra12.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Iron overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Metabolism and nutrition disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra12.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra12.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Dysphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra12.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra12.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra12.0 | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | meddra12.0 | View |
| Allergic rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra12.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra12.0 | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra12.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra12.0 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra12.0 | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra12.0 | View |
| Chest wall pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra12.0 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra12.0 | View |