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 @ 7:59 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT03711604
Description: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. This includes AE, SAE and adverse event of special interest.
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT03711604
Study Brief: Compassionate Use Study of Tenalisib (RP6530)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tenalisib (RP6530) Participants receive Tenalisib (RP6530) BID orally. 1 None 5 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal Cell Carcinoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated Aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Elevated Blood alkaline phosphotase SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophile count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Elevated Troponin SYSTEMATIC_ASSESSMENT Investigations None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Supraventriculat extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pnuemonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Exfoliative Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Obstruction SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View