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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT01277718
Description: Three participants discontinued study in second period and did not receive Cobimetinib \[Fasted\] + Rabeprazole in third period. Therefore, only 17 participants were evaluable for adverse events in the Cobimetinib \[Fasted\] + Rabeprazole treatment arm.
Frequency Threshold: 0
Time Frame: Adverse events were recorded from start of study treatment in first period to end of last period (up to 36 days)
Study: NCT01277718
Study Brief: A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cobimetinib [Fasted] One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. None None 0 20 8 20 View
Cobimetinib [Fasted] + Rabeprazole Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. None None 0 17 10 17 View
Cobimetinib [Fed] + Rabeprazole Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. None None 0 20 9 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Depressed level of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Scleral hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Vessel puncture site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Hyperacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Papule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View