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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT01320033
Description: None
Frequency Threshold: 5
Time Frame: From Baseline up to Week 16
Study: NCT01320033
Study Brief: Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CD2475/101 40 mg Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. 0 None 1 216 29 216 View
Doxycycline 100 mg Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. 0 None 4 223 51 223 View
Placebo Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. 0 None 2 222 29 222 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Affective disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.0) View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.0) View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (13.0) View
Forearm fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Multiple drug overdose intentional NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Uterine leiomyoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.0) View
Multiple sclerosis relapse NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View