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: 2025-12-24 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT02210559
Description: Safety population included all participants who had received any dose of study drug.
Frequency Threshold: 5
Time Frame: Adverse events were assessed from first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196). All-Cause Mortality was assessed from first infusion of any study drug until death, assessed up to 4 years.
Study: NCT02210559
Study Brief: A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic 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
Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P) Participants received gemcitabine at 1000 mg/m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received pamrevlumab at 35 mg/kg by IV infusion on Days 1 and 15 of each cycle. An additional dose of pamrevlumab was given on Day 8 of the first cycle. Participants received a total of up to six 28-day cycles of treatment. 17 None 9 24 24 24 View
Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP) Participants received gemcitabine at 1000 mg/ m\^2 plus nab-paclitaxel at 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each cycle. Participants received a total of up to six 28-day cycles of treatment. 7 None 6 13 12 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemolytic uraemic syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Lymphadenopthy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Device occlusions SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatic insufficiency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary toxicity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View