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 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT05014412
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 set evaluated. All-cause mortality: number of deaths are reported from Day 1 of the study up to 90 days post last dose and deaths which occurred after 90 days post last dose of study drug are also included.
Frequency Threshold:
5
Time Frame:
Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
Study:
NCT05014412
Study Brief:
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
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 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 13 | None | 23 | 33 | 33 | 33 | View |
| Part 2A: Dose Level 1 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 8 | None | 11 | 12 | 12 | 12 | View |
| Part 2A: Dose Level 2 | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 4 | None | 8 | 11 | 10 | 11 | View |
| Part 2B | Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. | 8 | None | 21 | 29 | 28 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Deafness bilateral | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Food poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v26.1 | View |
| Cytokine release syndrome | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v26.1 | View |
| Adenovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cytomegalovirus chorioretinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cytomegalovirus infection reactivation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cytomegalovirus viraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Enterovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Escherichia bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Fungaemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Parainfluenzae virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumocystis jirovecii pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia influenzal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia proteus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia pseudomonal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Sinusitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Soft tissue infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Streptococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Tumour lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Pathological fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Muscle neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Plasmacytoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Small intestine adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Immune effector cell-associated neurotoxicity syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v26.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.1 | View |
| Cytokine release syndrome | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v26.1 | View |
| Hypogammaglobulinaemia | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v26.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cytomegalovirus infection reactivation | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Cytomegalovirus viraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v26.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v26.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.1 | View |