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 @ 1:58 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
NCT ID:
NCT01614795
Description:
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01614795
Study Brief:
Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory 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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 Relapsed or Refractory Osteosarcoma | Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg). temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA. laboratory biomarker analysis: Correlative studies | None | None | 2 | 11 | 11 | 11 | View |
| Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET | Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg). temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA. laboratory biomarker analysis: Correlative studies | None | None | 3 | 11 | 5 | 11 | View |
| Group 3 Relapsed or Refractory Rhabdomyosarcoma | Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg). temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA. laboratory biomarker analysis: Correlative studies | None | None | 2 | 11 | 7 | 11 | View |
| Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma | Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg). temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA. laboratory biomarker analysis: Correlative studies | None | None | 7 | 12 | 6 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Multi-organ failure | None | General disorders | None | View |
| Non-cardiac chest pain | None | General disorders | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Pain | None | General disorders | None | View |
| Wound infection | None | Infections and infestations | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Urinary tract obstruction | None | Renal and urinary disorders | None | View |
| Weight loss | None | Investigations | None | View |
| White blood cell decreased | None | Investigations | None | View |
| Hypermagnesemia | None | Metabolism and nutrition disorders | None | View |
| Hypertriglyceridemia | None | Metabolism and nutrition disorders | None | View |
| Hyperuricemia | None | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | None | View |
| Infections and infestations - Other | None | Infections and infestations | None | View |
| Mucositis oral | None | Gastrointestinal disorders | None | View |
| Alanine aminotransferase increased | None | Investigations | None | View |
| Alkaline phosphatase increased | None | Investigations | None | View |
| Anaphylaxis | None | Immune system disorders | None | View |
| Ascites | None | Gastrointestinal disorders | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Blood bilirubin increased | None | Investigations | None | View |
| Cardiac disorders - Other | None | Cardiac disorders | None | View |
| Creatinine increased | None | Investigations | None | View |
| Duodenal obstruction | None | Gastrointestinal disorders | None | View |
| Fever | None | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Confusion | None | Psychiatric disorders | None | View |
| Creatinine increased | None | Investigations | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hyponatremia | None | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Lymphocyte count decreased | None | Investigations | None | View |
| Mucositis oral | None | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Pain | None | General disorders | None | View |
| Paronychia | None | Infections and infestations | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Tremor | None | Nervous system disorders | None | View |
| White blood cell decreased | None | Investigations | None | View |