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 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
NCT ID:
NCT01394003
Description:
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01394003
Study Brief:
A Study of LY2584702 in Participants With Advanced Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 25 mg LY2584702 QD | Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 2 | 3 | 2 | 3 | View |
| 50 mg LY2584702 QD | Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 2 | 8 | 7 | 8 | View |
| 100 mg LY2584702 QD | Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 1 | 3 | 2 | 3 | View |
| 200 mg LY2584702 QD | Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 2 | 6 | 5 | 6 | View |
| 50 mg LY2584702 BID | Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 1 | 3 | 3 | 3 | View |
| 75 mg LY2584702 BID | Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 1 | 3 | 3 | 3 | View |
| 100 mg LY2584702 BID | Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 3 | 6 | 6 | 6 | View |
| 300 mg LY2584702 BID | Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | None | None | 1 | 2 | 2 | 2 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v11.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Bile duct stenosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v11.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Blood amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v11.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v11.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.0 | View |
| Partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v11.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v11.0 | View |
| Ureteric obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v11.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v11.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v11.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v11.0 | View |
| Abnormal sensation in eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v11.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v11.0 | View |
| Ocular surface disease | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v11.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Faecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v11.0 | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v11.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v11.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v11.0 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v11.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v11.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v11.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v11.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v11.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v11.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v11.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v11.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v11.0 | View |
| Peroneal nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v11.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v11.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v11.0 | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v11.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v11.0 | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v11.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v11.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Skin odour abnormal | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v11.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v11.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v11.0 | View |