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 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
NCT ID:
NCT01731951
Description:
All treated analysis set included all participants who received at least 1 dose of Imetelstat. All non-serious adverse events (at 5% threshold) and serious adverse event including requirements for expedited reporting of serious adverse events occurring within 30 days of the last dose of study drug are reported.
Frequency Threshold:
5
Time Frame:
From first dose of study drug to the last dose of study drug or until subsequent anti-cancer therapy if earlier (Up to approximately 5.7 years)
Study:
NCT01731951
Study Brief:
Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts]) | Participants with MF and spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years). | 8 | None | 7 | 9 | 9 | 9 | View |
| Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts]) | Participants with MF without spliceosome mutations or ring sideroblasts present received 2 cycles (Cycles 1-2) of imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or imetelstat 7.5 mg/kg twice weekly on Days 1, 3 for 2 cycles of 28-day cycle (Cycles 3-4) followed by imetelstat 7.5 mg/kg 3-times-weekly on Days 1, 3, 5 of Cycles 5 and beyond of 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years). | 9 | None | 14 | 18 | 18 | 18 | View |
| Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts) | Participants with either MDS/MPN or MDS and spliceosome mutations or ring sideroblasts present received 2 cycles of 28-day cycle (Cycles 1-2) of imetelstat 7.5 mg/kg, IV as 2-hour infusion on Day 1 of a 28-day cycle followed by maintenance therapy with the same regimen or the possibility of dose escalation to imetelstat 9.4 mg/kg weekly if response to the initial dose was insufficient up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years). | 6 | None | 9 | 9 | 9 | 9 | View |
| Arm A: Imetelstat 9.4 mg/kg (MF) | Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Day 1 of each 21-day cycle in Core Phase up to 9 cycles. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years). | 13 | None | 17 | 19 | 19 | 19 | View |
| Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF) | Participants with MF regardless of spliceosome mutation status or presence of ring sideroblasts received imetelstat 9.4 mg/kg, IV as 2-hour infusion on Days 1, 8, and 15 of 21-day cycle in Cycle 1 followed by 9.4 mg/kg on Day 1 of each 21-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years). | 15 | None | 12 | 16 | 16 | 16 | View |
| Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia | Participants with blast-phase MF/AML received imetelstat 9.4 mg/kg, IV as 2-hour infusion weekly on Days 1, 8, 15, 22 of a 28-day cycle up to 9 cycles in the Core Phase. Participants could receive imetelstat beyond Cycle 9 in the Extension Phase if they did not meet any of the withdrawal criteria, did not have disease progression and were receiving clinical benefit from treatment as determined by the investigator. Following treatment discontinuation, participants entered the Event Monitoring Phase for collection of survival status, disease status, and subsequent treatment information (Up to approximately 5.7 years). | 9 | None | 9 | 9 | 9 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Blood amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |