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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT01150357
Description: None
Frequency Threshold: 5
Time Frame: Adverse events are collected from First Participant First Visit (FPFV) Baseline up to 8 weeks until Last Participant Last Visit (LPLV). All adverse events reported in this record are from date of First Participant First Treatment until LPLV.
Study: NCT01150357
Study Brief: Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1: Aliskiren Low (6.25/12.5/25 mg) Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren. None None 0 108 11 108 View
Phase 1: Aliskiren Mid (37.5/75/150 mg) Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren. None None 0 54 6 54 View
Phase 1: Aliskiren High (150/300/600 mg) Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren. None None 1 105 14 105 View
Phase 2: Aliskiren Low (6.25/12.5/25 mg) Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren. None None 0 50 8 50 View
Phase 2: Aliskiren Mid (37.5/75/150 mg) Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren. None None 0 30 7 30 View
Phase 2: Placebo Low Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily. None None 0 57 7 57 View
Phase 2: Placebo Mid Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily. None None 0 21 3 21 View
Phase 2: Placebo High Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily. None None 0 52 5 52 View
Phase 2: Aliskiren High (150/300/600 mg) Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren. None None 2 50 9 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View