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 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
NCT ID:
NCT02057692
Description:
One participant assigned to the 70μg/kg/day arm, was withdrawn from the study after receiving a single dose of 14 mcg/kg/day dose. TEAE was reported separately for this participant in a separate arm.
Frequency Threshold:
5
Time Frame:
From the start of study drug administration up to Week 17
Study:
NCT02057692
Study Brief:
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Maralixibat 14 mcg/kg/Day | Participants received 14 mcg/kg/day of maralixibat oral solution for 1 week. One participant assigned to the 70μg/kg/day arm, was withdrawn from the study after receiving a single dose of 14 mcg/kg/day dose. TEAE was reported separately for this participant using this arm. | 0 | None | 0 | 1 | 1 | 1 | View |
| Maralixibat 70 mcg/kg/Day | Participants received low dose maralixibat 70 mcg/kg/day oral solution for 10 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35 and 70 mcg/kg/day dose per each week respectively up to 3 weeks. | 0 | None | 1 | 7 | 7 | 7 | View |
| Maralixibat 140 mcg/kg/Day | Participants received mid dose maralixibat 140 mcg/kg/day oral solution for 9 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70 and 140 mcg/kg/day dose per each week respectively up to 4 weeks. | 0 | None | 0 | 11 | 9 | 11 | View |
| Maralixibat 280 mcg/kg/Day | Participants received high dose maralixibat 280 mcg/kg/day oral solution for 8 weeks during the stable dosing period, which was administered after a dose escalation period, in which participants received 14, 35, 70, 140 and 280 mcg/kg/day dose per each week respectively up to 5 weeks. | 0 | None | 0 | 6 | 5 | 6 | View |
| Placebo | Participants received placebo matched to maralixibat oral solution for 13 weeks (dose escalation and stable dosing period). | 0 | None | 0 | 12 | 12 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| Growing pains | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| Pallor | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Eye swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Lip swelling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Tooth crowding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| Left ventricular hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| Acarodermatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Pertussis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| Acoustic stimulation tests abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Gamma-Glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| Enuresis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.0) | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| Vitamin e deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Mood altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.0) | View |