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 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:36 AM
NCT ID:
NCT02517918
Description:
Safety population: all patients having received at least one treatment administration.
All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
Frequency Threshold:
0
Time Frame:
Safety profile was continuously followed : monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. In case of SAE, monitoring could be improved as per investigator's judgement. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 13 months.
Study:
NCT02517918
Study Brief:
Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Escalation Part With Sirolimus (Si) Dose 4 mg | Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design. Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days. Number of subjects : 6. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule. Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week. Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks. | None | None | 3 | 6 | 6 | 6 | View |
| Dose Escalation Part With Sirolimus (SI) Dose 6 mg | Prospective open-labeled phase I trial. The dose escalation design to identify the maximum tolerated dose will be the traditional 3+3 design. Sirolimus (SI) dose 6 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days. Number of subjects : 3. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule. Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week. Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks. | None | None | 3 | 3 | 3 | 3 | View |
| Expansion Cohort With Dose Sirolimus (SI) 4 mg | Prospective open-labeled phase I trial. The expansion cohort is designed to enable to detect antitumor activity observed with sirolimus (SI) combined with cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA). Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days. Number of subjects : 14. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule. Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week. Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks. | None | None | 9 | 14 | 14 | 14 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Version 4.0 (CTCAE) | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | Version 4.0 (CTCAE) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Version 4.0 (CTCAE) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Version 4.0 (CTCAE) | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | Version 4.0 (CTCAE) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Gum infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Version 4.0 (CTCAE) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| CPK increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 4.0 (CTCAE) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 4.0 (CTCAE) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 4.0 (CTCAE) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | Version 4.0 (CTCAE) | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Version 4.0 (CTCAE) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 4.0 (CTCAE) | View |
| Dysesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 4.0 (CTCAE) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 4.0 (CTCAE) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 4.0 (CTCAE) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Version 4.0 (CTCAE) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | Version 4.0 (CTCAE) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Version 4.0 (CTCAE) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Hoarseness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Sinus disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Version 4.0 (CTCAE) | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 4.0 (CTCAE) | View |
| Nail loss | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 4.0 (CTCAE) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 4.0 (CTCAE) | View |
| Skin hypopigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 4.0 (CTCAE) | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 4.0 (CTCAE) | View |
| Superior vena cava syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | Version 4.0 (CTCAE) | View |
| WORSENING OF GENERAL STATUS | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| INFLAMMATORY SYNDROM | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| LDH INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| CRP INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | Version 4.0 (CTCAE) | View |
| IRON DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| SUBCUTANEOUS NODULE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Version 4.0 (CTCAE) | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Version 4.0 (CTCAE) | View |
| NOCTURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Version 4.0 (CTCAE) | View |
| URINARY DISORDERS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Version 4.0 (CTCAE) | View |
| POLYURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | Version 4.0 (CTCAE) | View |
| VAGINAL ULCERATION | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | Version 4.0 (CTCAE) | View |
| ESCHAR OF THE SACRUM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Version 4.0 (CTCAE) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Version 4.0 (CTCAE) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | Version 4.0 (CTCAE) | View |
| HOT FLUSHES | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| POLYDYPSIA | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |
| ALTERATION OF GENERAL STATUS | SYSTEMATIC_ASSESSMENT | General disorders | Version 4.0 (CTCAE) | View |