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 @ 12:16 PM
Ignite Modification Date:
2025-12-25 @ 12:01 PM
NCT ID:
NCT00434161
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse Events were collected for a period of up to 222 days.
Study:
NCT00434161
Study Brief:
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Palifermin Before Only | Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set. | None | None | 13 | 111 | 110 | 111 | View |
| Placebo | Subjects to receive matched placebo before- and after-high dose chemotherapy | None | None | 3 | 57 | 56 | 57 | View |
| Palifermin Before and After | Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set. | None | None | 18 | 109 | 109 | 109 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Epiglottitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Febrile bone marrow aplasia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Graft complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.1) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Intervertebral discitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Mediastinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Melanodermia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Pneumonia primary atypical | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Pulmonary embolism | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Rash vesicular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.1) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Tongue discolouration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Edema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.1) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.1) | View |