Adverse Events Module

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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 @ 6:35 PM

Ignite Modification Date: 2025-12-25 @ 4:05 PM

NCT ID: NCT00788957

Description: None

Frequency Threshold: 5

Time Frame: All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.

Study: NCT00788957

Study Brief: Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Part 1: Panitumumab + Rilotumumab	Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	8	None	5	11	11	11	View
Part 2: Panitumumab Alone	Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	32	None	11	48	42	48	View
Part 2: Panitumumab + Rilotumumab	Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	35	None	9	48	47	48	View
Part 2: Panitumumab + Ganitumab	Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	37	None	9	46	44	46	View
Part 3: Rilotumumab	Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	8	None	6	13	11	13	View
Part 3: Ganitumab	Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	8	None	2	11	9	11	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Intestinal obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Small intestinal obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Upper gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
General physical health deterioration	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hyperbilirubinaemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Hip fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Eastern cooperative oncology group performance status worsened	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Cancer pain	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Colorectal cancer	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastases to central nervous system	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Metastases to liver	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Neoplasm	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Cerebrovascular accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Loss of consciousness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Renal failure acute	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Deep vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Colorectal cancer metastatic	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Dermatitis acneiform	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Disease progression	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Enterococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Hydronephrosis	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Hypercreatininaemia	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Arrhythmia supraventricular	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Ascites	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Capillary leak syndrome	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acne	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dermatitis acneiform	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Erythema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Nail disorder	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin fissures	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dry eye	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Oedema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Oropharyngeal pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dermatitis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hypertrichosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pain of skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Hypoacusis	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Otorrhoea	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Tinnitus	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Eye irritation	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Keratitis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Abdominal discomfort	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Anal inflammation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Cheilitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gingival pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Peritoneal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Face oedema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Facial pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
General physical health deterioration	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Inflammation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hepatic pain	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Drug hypersensitivity	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Anogenital warts	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin bacterial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vulvovaginal mycotic infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Contrast media reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Eye injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Procedural vomiting	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Blood calcium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood magnesium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood potassium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood pressure increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Body temperature increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Breath sounds abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypercalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Intervertebral disc protrusion	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myopathy	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pyogenic granuloma	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Neuropathy peripheral	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Paraesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Polyneuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Oliguria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Genital tract inflammation	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Hiccups	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nasal oedema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngeal inflammation	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Eczema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hirsutism	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Ingrowing nail	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Koilonychia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Palmar-plantar erythrodysaesthesia syndrome	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin hyperpigmentation	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin oedema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Capillary leak syndrome	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Glucose tolerance impaired	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hypersensitivity	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Musculoskeletal chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Dysarthria	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Flushing	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Gastrooesophageal reflux disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Glycosylated haemoglobin increased	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Hyperhidrosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperthyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Infusion site inflammation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Jaundice	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Leukopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Localised oedema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Procedural pain	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Renal failure chronic	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Renal impairment	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Vulvovaginal candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Paronychia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Decreased appetite	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscle spasms	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Lethargy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Gingival bleeding	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Conjunctivitis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dry mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View