Adverse Events Module

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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 @ 12:06 AM
Ignite Modification Date: 2025-12-25 @ 10:05 PM
NCT ID: NCT01186458
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01186458
Study Brief: Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fludarabine, Velcade and Rituximab Fludarabine, Velcade and Rituximab Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy. Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy. Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy. None None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
BLOOD/BONE MARROW - OTHER (SPECIFY, __) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAEv3 View
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
ATAXIA (INCOORDINATION) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
CONSTITUTIONAL SYMPTOMS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
CREATININE NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
DYSPNEA (SHORTNESS OF BREATH) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
FATIGUE (ASTHENIA, LETHARGY, MALAISE) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
HAIR LOSS/ALOPECIA (SCALP OR BODY) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv3 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv3 View
INFECTION - OTHER NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AERODIGESTIVE NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv3 View
LEUKOCYTES (TOTAL WBC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
LEUKOENCEPHALOPATHY (RADIOGRAPHIC FINDINGS) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
LYMPHOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA) NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv3 View
MOOD ALTERATION / AGITATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv3 View
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv3 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
NEUROPATHY: MOTOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
NEUROPATHY: SENSORY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv3 View
NEUTROPHILS/GRANULOCYTES (ANC/AGC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
NYSTAGMUS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv3 View
PAIN / ABDOMEN NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv3 View
PAIN / BACK NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PAIN / EXTREMITY-LIMB NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
PAIN / JOINT NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv3 View
PAIN / LYMPH NODE NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
PAIN - OTHER NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
PLATELETS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
RIGORS/CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
SEXUAL/REPRODUCTIVE FUNCTION - OTHER NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv3 View
SWEATING (DIAPHORESIS) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View
WATERY EYE (EPIPHORA, TEARING) NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv3 View
HEMOGLOBIN NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv3 View
HICCOUGHS (HICCUPS, SINGULTUS) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv3 View
MOOD ALTERATION / ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv3 View
PAIN / HEAD/HEADACHE NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv3 View