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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
NCT ID:
NCT01611558
Description:
None
Frequency Threshold:
5
Time Frame:
On or after Day 1 of study treatment and no later than 90 days following the last day of study treatment ( Up to 5 years).
Study:
NCT01611558
Study Brief:
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 10 mg/kg Ipilimumab | None | 35 | None | 26 | 40 | 40 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.0 | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.0 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Liver abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Incarcerated incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Ovarian cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.0 | View |
| Hypophysitis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 22.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |