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 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
NCT ID:
NCT00598702
Description:
Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Frequency Threshold:
5
Time Frame:
Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period.
Study:
NCT00598702
Study Brief:
Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours | None | None | 1 | 1 | 1 | 1 | View |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours | None | None | 1 | 3 | 1 | 3 | View |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours | None | None | 0 | 7 | 5 | 7 | View |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours | None | None | 13 | 33 | 24 | 33 | View |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours | None | None | 2 | 9 | 9 | 9 | View |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours | None | None | 3 | 42 | 33 | 42 | View |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours | None | None | 0 | 1 | 0 | 1 | View |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours | None | None | 1 | 4 | 2 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra (10.0) | View |
| Congenital Megacolon | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (10.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra (10.0) | View |
| Chylothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Diaphragmatic disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Hepatotoxicity | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Obstructive airways disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra (10.0) | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra (10.0) | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Catheter-Related Complication | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Wound Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Laryngotracheal oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Oliguria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Polyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Pruritis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Skin disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Sputum culture positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Stridor | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Infusion Site Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Vulvovaginal Mycotic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Gamma-Glutamyltransferase (GGT) Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| Hypervolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Urinary Retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Apnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pharyngolaryngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Rash Generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Wound Drainage | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.0) | View |
| Sedation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |