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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
NCT ID:
NCT02657005
Description:
Per clinicaltrials.gov definitions
Frequency Threshold:
5
Time Frame:
Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Study:
NCT02657005
Study Brief:
TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 18 mg/m^2 (7 Days) | Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216 | 2 | None | 1 | 3 | 3 | 3 | View |
| 36 mg/m^2 (7 Days) | Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216 | 2 | None | 1 | 3 | 3 | 3 | View |
| 72 mg/m^2 (7 Days) | Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216 | 3 | None | 1 | 3 | 3 | 3 | View |
| 144 mg/m^2 (7 Days) | Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216 | 3 | None | 1 | 3 | 3 | 3 | View |
| 200 mg/m^2 (10 Days) | Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216 | 4 | None | 4 | 4 | 4 | 4 | View |
| 200 mg/m^2 (14 Days) | Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216 | 2 | None | 1 | 4 | 4 | 4 | View |
| 220 mg/m^2 (7 Days) | Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle | 2 | None | 2 | 3 | 3 | 3 | View |
| 220 mg/m^2 (10 Days) | Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle | 3 | None | 1 | 3 | 3 | 3 | View |
| 288 mg/m^2 (7 Days) | Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle | 3 | None | 2 | 7 | 7 | 7 | View |
| Expansion | Expansion Segment (Cohort 10) where patients were treated with the schedule for RP2D of TK216 with vincristine 0.75 - 1.5 mg/m2 administered on the first day of each 28-day cycle | 26 | None | 21 | 44 | 44 | 44 | View |
| 175 mg/m^2 | Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor | 1 | None | 5 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Aortobronchial fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Hypoglossal nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Cancer Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v23.1 | View |
| Jugular vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.1 | View |
| Blood Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Pleuritic Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Catheter site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Complication associated with device | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Periorbital cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.1 | View |
| Lymphocyte cunt decrease | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.1 | View |