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 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
NCT ID:
NCT01092832
Description:
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
2
Time Frame:
Day 1 up to Day 49 (7 days after the last dose of study drug)
Study:
NCT01092832
Study Brief:
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Voriconazole: 2 to <12 Years | Participants aged 2 to \<12 years (and young adolescents aged 12 to 14 years weighing \<50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment. | None | None | 2 | 14 | 13 | 14 | View |
| Voriconazole: 12 to <18 Years | Participants aged 12 to \<18 years (excluding those aged 12-14 years weighing \<50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment. | None | None | 1 | 8 | 6 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Splenic candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.0 | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Pharyngeal erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Venoocclusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Hypothrombinaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Platelet disorder | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Amaurosis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Corneal opacity | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Eyelid disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Retinal disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Tongue ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Hypothermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Gallbladder disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Hepatosplenomegaly | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Liver disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Anorectal cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bone abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bronchopulmonary aspergillosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Splenic candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Incision site pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Refractoriness to platelet transfusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Transplant failure | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Alanine aminotransferase abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Aspartate aminotransferase abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood alkaline phophatase abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Drug level decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Gamma-glutamyltransferase abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Haematocrit abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Lymphocyte percentage abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Monocyte count abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Staphylococcus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypermagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypochloraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypophagia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Cystitis haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Testicular mass | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 16.0 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal 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 |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Hydrothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Hypoventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Dermatosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Scab | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |