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 @ 12:04 PM
Ignite Modification Date:
2025-12-25 @ 11:58 AM
NCT ID:
NCT02684461
Description:
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
Frequency Threshold:
0
Time Frame:
Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
Study:
NCT02684461
Study Brief:
Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A: Sequential Consolidation | Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles. Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles. | 1 | None | 1 | 7 | 7 | 7 | View |
| Arm B: Sequential Consolidation | Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21 Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles. Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles. | 1 | None | 1 | 7 | 7 | 7 | View |
| Arm C: Concurrent Consolidation | Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles. Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles. | 0 | None | 0 | 6 | 6 | 6 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE, version 4.0 | View |
| Atrioventricular block complete | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE, version 4.0 | View |
| Cardiac disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE, version 4.0 | View |
| Ear and labyrinth disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE, version 4.0 | View |
| Adrenal insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE, version 4.0 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE, version 4.0 | View |
| Blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE, version 4.0 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE, version 4.0 | View |
| Eye disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE, version 4.0 | View |
| Glaucoma | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE, version 4.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE, version 4.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE, version 4.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE, version 4.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE, version 4.0 | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE, version 4.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE, version 4.0 | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE, version 4.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE, version 4.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE, version 4.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE, version 4.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE, version 4.0 | View |
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE, version 4.0 | View |
| Gum infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE, version 4.0 | View |
| Papulopustular rash | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE, version 4.0 | View |
| Rhinitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE, version 4.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE, version 4.0 | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE, version 4.0 | View |
| Vaginal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE, version 4.0 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE, version 4.0 | View |
| Intraoperative neurological injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE, version 4.0 | View |
| Activated partial thromboplastin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Cholesterol high | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Investigations - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Hypermagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hyperuricemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE, version 4.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE, version 4.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE, version 4.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE, version 4.0 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE, version 4.0 | View |
| Renal and urinary disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE, version 4.0 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE, version 4.0 | View |
| Urinary urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE, version 4.0 | View |
| Bronchopulmonary hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE, version 4.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Hoarseness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Postnasal drip | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Sleep apnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Sore throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE, version 4.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE, version 4.0 | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE, version 4.0 | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE, version 4.0 | View |
| Surgical and medical procedures - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE, version 4.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE, version 4.0 | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE, version 4.0 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE, version 4.0 | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE, version 4.0 | View |
| Allergic rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Bronchial obstruction | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE, version 4.0 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE, version 4.0 | View |
| Blood and lymphatic system disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE, version 4.0 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE, version 4.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE, version 4.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE, version 4.0 | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE, version 4.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE, version 4.0 | View |
| Joint range of motion decreased lumbar spine | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Musculoskeletal and connective tissue disorder - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE, version 4.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE, version 4.0 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE, version 4.0 | View |
| Tumor pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE, version 4.0 | View |
| Aphonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE, version 4.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE, version 4.0 | View |