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 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
NCT ID:
NCT04267120
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Study:
NCT04267120
Study Brief:
Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lenvatinib + Pembrolizumab | * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria. | 8 | None | 6 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Jejunal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
| New prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Scalp sores | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Sensitive hands | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Sensitive skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Facial abrasions | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Skin soreness | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Sores above pubis area | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Warm hands and feet | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Vitiligo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Hernia surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (Unspecified) | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (Unspecified) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (Unspecified) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (Unspecified) | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (Unspecified) | View |
| Adrenal insuffciency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (Unspecified) | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Vision decreased | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (Unspecified) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dental pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Fecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Hemorrhoidal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Intra-abdominal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Stomach pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (Unspecified) | View |
| Pain - bottom of feet | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Generalized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| Sweating | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (Unspecified) | View |
| COVID-19 infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (Unspecified) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Blood bicarbonate increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (Unspecified) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyperphosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (Unspecified) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Hip pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Muscle weakness upper limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Restless leg syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (Unspecified) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (Unspecified) | View |
| Amenorrhea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (Unspecified) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Postnasal drip | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Voice alteration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Erythematous rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Face sores | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Itchy scalp | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Nail discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Palmar-plantar erythrodysesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Pruritic rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | View |