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:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
NCT ID:
NCT02663518
Description:
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.
Frequency Threshold:
5
Time Frame:
Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Study:
NCT02663518
Study Brief:
A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
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: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 0 | None | 1 | 3 | 2 | 3 | View |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 1 | None | 0 | 3 | 3 | 3 | View |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 1 | None | 1 | 7 | 7 | 7 | View |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 1 | None | 2 | 5 | 5 | 5 | View |
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 52 | None | 43 | 107 | 100 | 107 | View |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen. | 27 | None | 13 | 40 | 34 | 40 | View |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 16 | None | 15 | 42 | 36 | 42 | View |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 0 | None | 1 | 3 | 3 | 3 | View |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 0 | None | 1 | 3 | 2 | 3 | View |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 2 | None | 2 | 6 | 6 | 6 | View |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 0 | None | 0 | 3 | 3 | 3 | View |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg | Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 5 | None | 3 | 12 | 12 | 12 | View |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred. | 1 | None | 3 | 4 | 4 | 4 | View |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen. | 0 | None | 2 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia Fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Abdominal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Bronchitis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Campylobacter Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Covid-19 Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Cytomegalovirus Infection Reactivation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Hepatic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pelvic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia Aspiration | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Septic Shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Staphylococcal Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Staphylococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Staphylococcal Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Spinal Compression Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Hip Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Humerus Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Febrile Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Haemolytic Uraemic Syndrome | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Thrombotic Thrombocytopenic Purpura | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Depressed Level Of Consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Cardio-Respiratory Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Mouth Ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Diabetic Ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypervolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Painful Respiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Acute Erythroid Leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Acute Myeloid Leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Cutaneous T-Cell Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Malignant Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Myelodysplastic Syndrome | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Mental Status Changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Major Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Graft Versus Host Disease | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v25.1 | View |
| Haemophagocytic Lymphohistiocytosis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v25.1 | View |
| Influenza A Virus Test Positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Platelet Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Pain In Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Adrenal Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v25.1 | View |
| Dermatitis Exfoliative Generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Intramedullary Rod Insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Pain In Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Platelet Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Neutrophil Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |