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 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
NCT ID:
NCT00556504
Description:
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study.
one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
Frequency Threshold:
5
Time Frame:
72 weeks
Study:
NCT00556504
Study Brief:
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TCM-700C (Safety Population) | TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C | None | None | 9 | 41 | 41 | 41 | View |
| Placebo (Safety Population) | Placebo with convetional treatment(PegIFN plus RBV) for HCV patients | None | None | 6 | 42 | 40 | 42 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Urinary infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | Serious | View |
| Fever/pain | SYSTEMATIC_ASSESSMENT | General disorders | Serious | View |
| block stools | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | Serious | View |
| sinusitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | Serious | View |
| hearing impairment | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Rhinorhea | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.1) | View |
| neuritic depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| lose weight | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Palpiations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.1) | View |
| Goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.1) | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.1) | View |
| Conjunctivities | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.1) | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.1) | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal distention | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Apthous stomatits | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Hemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Irritable bowel syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Peptic ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Reflux esophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Gallbladder polyp | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.1) | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Edema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hyperuricaemi | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Skin disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Synovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Tenosynovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Hypoesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Mood altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.1) | View |
| Urinary incontinency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.1) | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.1) | View |
| Bronchitis chronic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Rash pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |