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 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
NCT ID:
NCT03933904
Description:
Subjects were monitored for all previously reported AEs associated with sirolimus treatment, possible new AEs, and any Grade 2 or higher allergic reaction or hypersensitivity attributed to sirolimus, as judged by the site investigator. AEs were defined according to the NCI CTCAE version 5.0, November 2017. All AEs were recorded in the source document.
Frequency Threshold:
0
Time Frame:
Adverse events were collected from baseline to study completion (up to 73 weeks).
Study:
NCT03933904
Study Brief:
Sirolimus in Previously Treated Idiopathic Multicentric Castleman Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sirolimus | For adults, the treatment began with a loading dose of 5 mg/m² on Day 1, designed to quickly achieve therapeutic levels of sirolimus. This loading dose was rounded to the nearest milligram and could be adjusted at the discretion of the prescribing physician based on individual tolerability and clinical judgment. | 0 | None | 1 | 7 | 7 | 7 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE version 5 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Bile duct stenosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTCAE version 5 | View |
| Blood and lymphatic system disorders-Other, specify | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE version 5 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE version 5 | View |
| Covid-19 Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE version 5 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTCAE version 5 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE version 5 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Itchy on palms | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE version 5 | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE version 5 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE version 5 | View |
| Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE version 5 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE version 5 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Tremors | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE version 5 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE version 5 | View |
| Respiratory, thoracic and mediastinal disorders - Other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Skin and subcutaneous tissue disorders - Other, specify (ankle) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Skin and subcutaneous tissue disorders - Other, specify (groin) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Skin and subcutaneous tissue disorders - Other, specify (torso) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Skin and subcutaneous tissue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE version 5 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Dry cough (worsening) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE version 5 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE version 5 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE version 5 | View |
| Ascites (worsening) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Edema limb (leg swelling) | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE version 5 | View |
| Lip pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE version 5 | View |
| Swelling of hands and feet (Edema limbs) | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE version 5 | View |
| Vascular disorders - Other | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE version 5 | View |
| Worsening of night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Worsening of rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE version 5 | View |
| Pain (whole body) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE version 5 | View |
| Lump on knee | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE version 5 | View |
| Gastrointestinal disorders - Other (tongue ulcer) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Mucositis oral (mouth sores) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE version 5 | View |
| Generalized muscle weakness (worsening) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE version 5 | View |