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 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
NCT ID:
NCT01040832
Description:
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
Frequency Threshold:
5
Time Frame:
Time from first dose up to Day 42 to 49 after last dose of trial treatment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)
Study:
NCT01040832
Study Brief:
EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cetuximab Plus EMD 1201081 | Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] over 120 minutes followed by 250 mg/m\^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram \[mg/kg\] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months. | None | None | 27 | 54 | 51 | 54 | View |
| Cetuximab Monotherapy | Cetuximab weekly (initial dose 400 mg/m\^2 over 120 minutes followed by 250 mg/m\^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months. | None | None | 23 | 53 | 53 | 53 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CARDIAC FAILURE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| PERICARDIAL EFFUSION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| ADDISON'S DISEASE | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 14.1 | View |
| ASCITES | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| DYSPHAGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| ILEUS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| TONGUE HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| DEATH | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| DEVICE LEAKAGE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| DISEASE PROGRESSION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| FACE OEDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| PNEUMATOSIS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| ERYSIPELAS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| PSEUDOMONAL SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| SUBCUTANEOUS ABSCESS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| WOUND INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| GASTROINTESTINAL STOMA COMPLICATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| TRACHEOSTOMY MALFUNCTION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| HAEMOGLOBIN DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| CACHEXIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| HYPERCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| HYPERKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| MALNUTRITION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| ARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| NECK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| METASTASES TO LIVER | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| METASTASES TO MENINGES | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| TUMOUR HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| PRESYNCOPE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| SPINAL CORD COMPRESSION | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| CONFUSIONAL STATE | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| URETHRAL STENOSIS | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| LARYNGEAL OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| OBSTRUCTIVE AIRWAYS DISORDER | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| PNEUMONIA ASPIRATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| PNEUMOTHORAX | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| RESPIRATORY FAILURE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| DEEP VEIN THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| DRUG HYPERSENSITIVITY | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.1 | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| BRONCHOPNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| CATHETER SITE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| DEVICE RELATED INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| TUMOUR NECROSIS | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| POLYNEUROPATHY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| ABDOMINAL PAIN UPPER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| DYSPHAGIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| INJECTION SITE ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| INJECTION SITE INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| INJECTION SITE PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| INJECTION SITE REACTION | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| CATHETER SITE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| DECREASED APPETITE | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| HYPERCALCAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| HYPOMAGNESAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| NECK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| PAIN IN EXTREMITY | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| CANCER PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| INFECTED NEOPLASM | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| TUMOUR HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| TUMOUR PAIN | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| ANXIETY | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| DYSPNOEA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| PRODUCTIVE COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| ACNE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| HYPERHIDROSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| SKIN FISSURES | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |