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 @ 5:55 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
NCT ID:
NCT01199068
Description:
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Study:
NCT01199068
Study Brief:
CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CS-7017 0.25 mg BID; Initial Portion | Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. | 1 | None | 1 | 3 | 3 | 3 | View |
| CS-7017 0.50 mg BID; Initial Portion | Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. | 1 | None | 3 | 3 | 3 | 3 | View |
| CS-7017 0.50 mg BID; Additional Portion | Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. | 0 | None | 4 | 8 | 8 | 8 | View |
| Overall | All participants who received CS-71017 in combination with erlotinib. | 2 | None | 8 | 14 | 14 | 14 | View |
| CS-7017 0.50 mg BID; Initial + Additional Portions | Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions). | 1 | None | 7 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Bronchial haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Metastatic pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Sinus arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Peripheral coldness | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Bronchial haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Nasal dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Nasal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Anal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Anal pruritus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Anorectal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastritis atropic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Retching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Scrotal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 14.1 | View |
| Scrotal swelling | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 14.1 | View |
| Hydrocele | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 14.1 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood creatinine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Brain natriuretic peptide increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Electrocardiogram QC prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Metastases to abdominal cavity | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Metastatic pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |