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 @ 1:20 AM
Ignite Modification Date: 2025-12-25 @ 11:28 PM
NCT ID: NCT03036293
Description: Adverse/Serious adverse events were registered in patients of the Safety population (n=390).
Frequency Threshold: 0
Time Frame: During the study (12 weeks).
Study: NCT03036293
Study Brief: Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tenoten, 2 Tablets Twice Daily (4 Tablets/Day) Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal. Tenoten: Tablet for oral use. 0 None 0 127 8 127 View
Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day) Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal. Tenoten: Tablet for oral use. 0 None 0 131 12 131 View
Placebo-2 + Placebo-4 Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily) Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed. 0 None 0 132 17 132 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Chronic tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Menstruation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Nasal septum deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Occipital neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Retinal vascular disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View