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 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
NCT ID:
NCT01016769
Description:
None
Frequency Threshold:
5
Time Frame:
2 years
Study:
NCT01016769
Study Brief:
Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
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 1, Dose Level 1 | Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5 | 4 | None | 2 | 4 | 4 | 4 | View |
| Phase 1, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 | 7 | None | 5 | 7 | 7 | 7 | View |
| Phase 1, Dose Level 2 | Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC | 6 | None | 4 | 7 | 7 | 7 | View |
| Phase 2, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 | 28 | None | 21 | 30 | 30 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conduct abnorm AV Block- 2nd deg Mobitz type II | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Death not assoc w CTCAE term- Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysphagia (Difficulty swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema: head and neck | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Fever (in the absence of neutropenia) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fistula, pulm/upp respir - Trachea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hemorrhage, Bronchopulmonary NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemorrhage, Nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemorrhage, Rectum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hemorrhage, Upper GI NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Inf norm ANC/gr1/2 neut-Pneumonia(lung) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Inf unknown ANC-Peripheral nerve | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Inf unknown ANC-Pneumonia(lung) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection w/ Gr 3/4 neut, Bone (osteomyelitis) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection w/ Gr 3/4 neut, Lung (pneumonia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| INR | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Mental status | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Muscle weakness - Whole body/general | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ophthalmoplegia/diplopia (double vision) | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Pain - Abdomen NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain - Face | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Neck | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain - Throat/pharynx/larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pain - Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Phosphate, low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulm/upp respiratory - Other (spec) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Stricture/stenosis, Esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope (fainting) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Thyroid function, high | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Vitreous hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Albumin, low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Allerg rhinitis (w sneez, nas stuff, postnas drip) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Bronchospasm, wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Calcium, high (hypercalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Calcium, low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Calcium, low (hypocalcemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dyspnea (shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Fever (in the absence of neutropenia) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| INR | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pneumonia/Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Magnesium, low (hypomagnesemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Mucositis - oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain - Extremity-limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Potassium, high (hyperkalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Sodium, low (hyponatremia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Vision-blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Pain - Throat/pharynx/larynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Weight Loss | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hair loss/alopecia (scalp or body) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hemorrhage, Bronchopulmonary NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pain - Chest/thorax NOS | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Phosphate, low (hypophosphatemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Potassium, low (hypokalemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pain - Dental/Teeth/Peridontal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Joint Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Trismus (dffclty,pain whn opn mouth) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain - Muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Creatinine | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Glucose, low (hypoglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pain - back | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema: limb | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infection, other | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash: erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Voice changes/dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry eye syndrome | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Mood alteration - Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pain - External ear | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Pain - Neck | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pruritus/itching | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vent arrhythmia- Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pain - Chest wall | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Ocular/Visual - Other (specify) | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Fistula, GI- Oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Allerg rhinitis (w sneez, nas stuff, postnas drip) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemorrhage, Nose | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash: acne/acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Watery eye (epiphora, tearing) | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Taste alteration (dysgeusia) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dry mouth/salivary gland (xerostomia) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hemorrhage/Bleeding, other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Flu-like syndrome | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Abdomen NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dermatology/Skin, other | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Muscle weakness - Extremity-lower | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Gastritis (incl bile reflux gastritis) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Auditory/Ear, other | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Thyroid function, low | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| PTT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Sweating (diaphoresis) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Mood alteration - Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Neuropathy: motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Albumin, low (hypoalbuminemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Glucose, high (hyperglycemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocytes (total WBC) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain - Pain NOS | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Platelets | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Cholesterol,high(hypercholestremia) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Edema: head and neck | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neuropathy: sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pain - face | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Trglycrde, high (hypertriglyceridemia) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| ALT, SGPT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Dysphagia (Difficulty swallowing) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| AST, SGOT | SYSTEMATIC_ASSESSMENT | Investigations | None | View |