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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT00246012
Description:
None
Frequency Threshold:
5
Time Frame:
Day 1 up to Follow-up period (30 days post-last dose).
Study:
NCT00246012
Study Brief:
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intetumumab 3 mg/kg [Phase 1 (Part 1)] | Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed. | None | None | 2 | 3 | 3 | 3 | View |
| Intetumumab 5 mg/kg [Phase 1 (Part 1)] | Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed. | None | None | 1 | 3 | 3 | 3 | View |
| Intetumumab 10 mg/kg [Phase 1 (Part 1)] | Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. | None | None | 0 | 3 | 2 | 3 | View |
| Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] | Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m\^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion. | None | None | 1 | 3 | 3 | 3 | View |
| Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] | Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion. | None | None | 2 | 3 | 3 | 3 | View |
| Dacarbazine + Placebo [Phase 2] | Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone. | None | None | 9 | 31 | 30 | 31 | View |
| Intetumumab 5 mg/kg [Phase 2] | Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. | None | None | 4 | 31 | 30 | 31 | View |
| Intetumumab 10 mg/kg [Phase 2] | Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. | None | None | 6 | 33 | 32 | 33 | View |
| Dacarbazine + Intetumumab 10 mg/kg [Phase 2] | Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m\^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion. | None | None | 7 | 32 | 30 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis Norovirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Wound Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V10.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Basal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Malignant Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Metastases to Central Nervous System | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Neoplasm Progression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Skin Neoplasm Bleeding | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Tumour Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Hypotonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Reversible Posterior Leukoencephalopathy Syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA V10.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Pneumonia Aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V10.0 | View |
| Pallor | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V10.0 | View |
| Febrile Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Cyanosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA V10.0 | View |
| Eye Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Disease Progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| General Physical Health Deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Anaphylactic Reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA V10.0 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA V10.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V10.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA V10.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA V10.0 | View |
| Hyperparathyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA V10.0 | View |
| Eye Irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Eye Pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Lacrimation Increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Ocular Discomfort | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Ocular Hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Uveitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Visual Acuity Reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Vitreous Floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V10.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Abdominal Pain Lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Abdominal Tenderness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Rectal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V10.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Infusion Site Extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Infusion Site Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V10.0 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Oral Herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V10.0 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA V10.0 | View |
| Wound Secretion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA V10.0 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V10.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V10.0 | View |
| Blood Lactate Dehydrogenase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V10.0 | View |
| Heart Rate Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V10.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V10.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V10.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V10.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V10.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V10.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V10.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Musculoskeletal Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V10.0 | View |
| Tumour Pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V10.0 | View |
| Disturbance in Attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Neuropathy Peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V10.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA V10.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA V10.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA V10.0 | View |
| Libido Decreased | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA V10.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA V10.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA V10.0 | View |
| Menstruation Irregular | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA V10.0 | View |
| Sexual Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA V10.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Pharyngolaryngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Pulmonary Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V10.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Vitiligo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V10.0 | View |
| Hot Flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V10.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V10.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V10.0 | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V10.0 | View |