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 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
NCT ID:
NCT02187003
Description:
Same event may appear as AE and SAE, what is presented are distinct events. Safety analysis set population included all participants who received at least one 1 infusion of study drug. Participants aged 12 years and above were identified as Cohort 1 and participants aged 6-11 years were identified as Cohort 2; however, the primary analysis and study conclusions were based on the full study population.
Frequency Threshold:
2
Time Frame:
Day 1 up to the 35-day post discharge visit (up to an average of Day 43)
Study:
NCT02187003
Study Brief:
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rivipansel Treatment Arm | Participants with sickle cell disease (SCD) received intravenous (IV) infusion of rivipansel while hospitalized for treatment of a vaso-occlusive crisis (VOC). Participants aged \>=12 years, with body weight \>40 kilogram (kg) received a loading dose of 1680 milligram (mg) rivipansel on Day 1 followed by maintenance doses of 840 mg rivipansel administered at 12 hourly intervals. Participants aged 6 to 11 years or any participant weighing \<=40 kg received a loading dose of 40 milligram per kilogram body weight (mg/kg) rivipansel on Day 1 (maximum of 1680 mg) followed by maintenance doses of 20 mg/kg rivipansel (maximum of 840 mg) administered at 12 hourly intervals. Participants received rivipansel until they met the protocol-defined criteria for readiness-for-discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days. | 0 | None | 52 | 162 | 137 | 162 | View |
| Placebo Treatment Arm | Participants with SCD received IV infusion of placebo (matched to rivipansel infusion) while hospitalized for treatment of a VOC. Participants received placebo on the same schedule used for rivipansel until they met the protocol-defined criteria for readiness-for- discharge from hospital or up to a maximum of 15 doses (1 loading dose and 14 maintenance doses), whichever occurred first. Dosing therefore continued for a maximum of 8 days | 0 | None | 49 | 158 | 124 | 158 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.0 | View |
| Sickle cell anaemia with crisis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.0 | View |
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Lip blister | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Multiple organ dysfunction syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Systemic inflammatory response syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v22.0 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v22.0 | View |
| Beta haemolytic streptococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Parainfluenzae virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pilonidal cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Staphylococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Thrombophlebitis septic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Vascular device infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Delayed haemolytic transfusion reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Blood culture positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Chest X-ray abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Fluid overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.0 | View |
| Bone infarction | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Hallucination | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Priapism | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v22.0 | View |
| Acute chest syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Acute generalised exanthematous pustulosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Swelling face | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.0 | View |
| Sickle cell anaemia with crisis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v22.0 | View |
| Sickle cell disease | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v22.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Ocular icterus | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v22.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Oxygen saturation decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v22.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Acute chest syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v22.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.0 | View |