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 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT01114204
Description:
None
Frequency Threshold:
1
Time Frame:
None
Study:
NCT01114204
Study Brief:
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ferumoxytol | Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g. | None | None | 17 | 406 | 95 | 406 | View |
| Iron Sucrose | Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries. | None | None | 5 | 199 | 69 | 199 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Atrioventricular block second degree | None | Cardiac disorders | MedDRA (13.0) | View |
| Tachycardia | None | Cardiac disorders | MedDRA (13.0) | View |
| Gastric ulcer haemorrhage | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gastrointestinal obstruction | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Asthenia | None | General disorders | MedDRA (13.0) | View |
| Pyrexia | None | General disorders | MedDRA (13.0) | View |
| Hepatic cirrhosis | None | Hepatobiliary disorders | MedDRA (13.0) | View |
| Anaphylactic reaction | None | Immune system disorders | MedDRA (13.0) | View |
| Bartholin's abscess | None | Infections and infestations | MedDRA (13.0) | View |
| Bronchopneumonia | None | Infections and infestations | MedDRA (13.0) | View |
| Rectal abscess | None | Infections and infestations | MedDRA (13.0) | View |
| Viraemia | None | Infections and infestations | MedDRA (13.0) | View |
| Road traffic accident | None | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Spinal osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Myelodysplastic syndrome | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Neoplasm progression | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Tumour haemorrhage | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Uterine leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Dysuria | None | Renal and urinary disorders | MedDRA (13.0) | View |
| Uterine haemorrhage | None | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Angioedema | None | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Hypertension | None | Vascular disorders | MedDRA (13.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Dry mouth | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Chest discomfort | None | General disorders | MedDRA (13.0) | View |
| Pyrexia | None | General disorders | MedDRA (13.0) | View |
| Chills | None | General disorders | MedDRA (13.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (13.0) | View |
| Cystitis | None | Infections and infestations | MedDRA (13.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (13.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (13.0) | View |
| White blood cell count decreased | None | Investigations | MedDRA (13.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Headache | None | Nervous system disorders | MedDRA (13.0) | View |
| Dizziness | None | Nervous system disorders | MedDRA (13.0) | View |
| Dysgeusia | None | Nervous system disorders | MedDRA (13.0) | View |
| Dysmenorrhoea | None | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Hypertension | None | Vascular disorders | MedDRA (13.0) | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Fatigue | None | General disorders | MedDRA (13.0) | View |
| Oedema peripheral | None | General disorders | MedDRA (13.0) | View |
| Feeling hot | None | General disorders | MedDRA (13.0) | View |
| Injection site pain | None | General disorders | MedDRA (13.0) | View |
| Hypersensitivity | None | Immune system disorders | MedDRA (13.0) | View |
| Drug hypersensitivity | None | Immune system disorders | MedDRA (13.0) | View |
| Influenza | None | Infections and infestations | MedDRA (13.0) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (13.0) | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Lymphocyte count decreased | None | Investigations | MedDRA (13.0) | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA (13.0) | View |
| Blood urea decreased | None | Investigations | MedDRA (13.0) | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Somnolence | None | Nervous system disorders | MedDRA (13.0) | View |
| Hypotension | None | Vascular disorders | MedDRA (13.0) | View |