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: NCT01790659
Description: AE's including application site reactions including elicited examination for pain, and clinician examination for erythema/redness, swelling/edema and vesicles. Physical examination findings of evidence of mucosal leishmaniasis will be reported as an AE.
Frequency Threshold: 0
Time Frame: AE's were assessed at baseline, days 2-9 daily, day 20, 35, 49, 63, 100, and 168 (applicable)
Study: NCT01790659
Study Brief: Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
WR 279,396 (Paromomycin and Gentamicin Topical Cream) WR 279,396: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5% 0 None 2 201 201 201 View
Paromomycin Paromomycin alone Paromomycin: Paromomycin alone 0 None 1 198 198 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Second degree burn: scalding water NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Appendectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Appendectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Infection of surgical site NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Abdominal pain (upper) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Application site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Application site erosion SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Application site injury SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal erosion SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cutaneous Leishmaniasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mucocutaneous Leishmaniasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyoderma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Superinfection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthrpod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Skin erosion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View