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 @ 10:04 PM
Ignite Modification Date: 2025-12-25 @ 7:40 PM
NCT ID: NCT02401035
Description: Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
Frequency Threshold: 0
Time Frame: From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Study: NCT02401035
Study Brief: PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 (>=1 to < 2 Years) Participants aged \>= 1 year to \< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning. 0 None 0 2 0 2 View
Cohort 2 (>=2 to <16 Years) Participants aged \>= 2 to \< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning. 0 None 1 16 8 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rotavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v25.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.1 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Catheter site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Vessel puncture site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Epiphyses delayed fusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.1 View
Adenoidal hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.1 View