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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT01939366
Description: None
Frequency Threshold: 5
Time Frame: Safety Analysis Set Baseline Visit (Day 1) to End of Maintenance Phase (Day 57).
Study: NCT01939366
Study Brief: Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cebranopadol 100 µg Cebranopadol 100 µg: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day. 0 None 1 64 47 64 View
Cebranopadol 300 µg Cebranopadol 300 µg: Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day. 0 None 2 61 50 61 View
Cebranopadol 600 µg Cebranopadol 600 µg: Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day. 0 None 4 62 53 62 View
Pregabalin Pregabalin: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks. 0 None 1 65 49 65 View
Matching Placebo Matching Placebo: Placebo will be matched to pregabalin and cebranopadol. 0 None 2 62 43 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Hypoglycaemic Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Diverticulum Intestinal Haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View