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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT01097460
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT01097460
Study Brief: MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MM-111 + Herceptin MM-111 will be combined with Herceptin MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV None None 2 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MeDRA 13.1 View
TRACHEAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 13.1 View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 13.1 View
DEEP VEIN THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MeDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 13.1 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
MUCOSAL INFLAMMATION NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
LOCALISED OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MeDRA 13.1 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 13.1 View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 13.1 View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 13.1 View
OROPHARYNGEAL PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA 13.1 View
DECREASED APPETITE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 13.1 View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 13.1 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 13.1 View
HYPOPHOSPHATAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MeDRA 13.1 View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13.1 View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13.1 View
NAIL DISORDER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13.1 View
NIGHT SWEATS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13.1 View
PHOTOSENSITIVITY REACTION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13.1 View
SKIN LESION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 13.1 View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 13.1 View
LEUKOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 13.1 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 13.1 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 13.1 View
COCCYDYNIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 13.1 View
MUSCLE SPASMS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 13.1 View
MUSCLE TWITCHING NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 13.1 View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 13.1 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
NEUROPATHY PERIPHERAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
DYSARTHRIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
HYPOAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
MIGRAINE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
RESTLESS LEGS SYNDROME NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 13.1 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13.1 View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13.1 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13.1 View
SINUSITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13.1 View
SKIN INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 13.1 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 13.1 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 13.1 View
CONFUSIONAL STATE NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 13.1 View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 13.1 View
ASPARATATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MeDRA 13.1 View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MeDRA 13.1 View
BLOOD UREA INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MeDRA 13.1 View
CARDIAC MURMUR NON_SYSTEMATIC_ASSESSMENT Investigations MeDRA 13.1 View
ARTHROPOD BITE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 13.1 View
COMPRESSION FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 13.1 View
TRACHEAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 13.1 View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MeDRA 13.1 View
TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MeDRA 13.1 View
PHOTOPHOBIA NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA 13.1 View
VISION BLURRED NON_SYSTEMATIC_ASSESSMENT Eye disorders MeDRA 13.1 View
DEEP VEIN THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MeDRA 13.1 View
HOT FLASH NON_SYSTEMATIC_ASSESSMENT Vascular disorders MeDRA 13.1 View
EAR PAIN NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MeDRA 13.1 View
URINARY TRACT PAIN NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MeDRA 13.1 View
BREAST PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MeDRA 13.1 View
SINUS OPERATION NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MeDRA 13.1 View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders MeDRA 13.1 View
LYMPHOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 13.1 View