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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
NCT ID:
NCT00493467
Description:
None
Frequency Threshold:
3
Time Frame:
Adverse events collected during treatment period including time from first Rituxan infusion (through Day 8) up to 12 weeks following Zevalin infusion.
Study:
NCT00493467
Study Brief:
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Zevalin | Ibritumomab Tiuxetan (Zevalin): 111In Zevalin (5 mCi of \^111In, 1.6 mg of Ibritumomab Tiuxetan) intravenous (IV) over 10 minutes on Day 1; 90Y Zevalin 0.3 or 0.4 mCi/kg IV over 10 minutes on Day 8. Rituximab: 250 mg/m\^2 IV over 4-6 Hours on Days 1 and 8 prior to the administration of 111In Zevalin and 90Y Zevalin, respectively. | None | None | 1 | 31 | 29 | 31 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMEN PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| ABDOMINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| ALLERGIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| ALLERGIC RHINITIS | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| BLADDER INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| BLURRED VISION | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| BRUISING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| DYSPNEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| EDEMA: HEAD AND NECK | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| EDEMA: LIMB | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| FEVER WITHOUT NEUTROPHIL INCREASE | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| LEUKOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| MUSCLE SPASM | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| NEUROPATHY: SENSOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| NEUTROPHILS CHANGE (Absolute neutrophil count (ANC)) | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| PAIN (ABDOMEN NOS) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PAIN (BACK) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN (HEAD/HEADACHES) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| PAIN (JOINT) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN (MUSCLE) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| PAIN PELVIC | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| PERFORATION, GI | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PLATELETS, DECREASE | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| PROPTOSIS/Enophthalmos | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| RASH/DESQUAMATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| THROMBOSIS/THROMBUS | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| VAGINAL BLEEDING | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| HEARTBURN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| HEMOGLOBIN INCREASE | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| HEMORRHAGE, PULMONARY | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| INFECTION UNKNOWN | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| REDNESS OF EYES | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| RIGORS/CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| SWEATING | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| INFECTION WITHOUT NEUTROPHIL INCREASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |