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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT01818258
Description: Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
Frequency Threshold: 5
Time Frame: From study entry to study completion at Week 48 or premature study discontinuation
Study: NCT01818258
Study Brief: IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Severe Malnutrition Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r 3 None 9 25 25 25 View
Normal Nutrition/Mild Malnutrition Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r 0 None 5 27 25 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Poor feeding infant SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Underweight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Selective eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Use of accessory respiratory muscles SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Plasmodium falciparum infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Tinea faciei SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Tympanic membrane hyperaemia SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View