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 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
NCT ID:
NCT01013350
Description:
Safety analysis set included all participants in the current study who either received placebo matched to cladribine or cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).
Frequency Threshold:
5
Time Frame:
up to 3251 days
Study:
NCT01013350
Study Brief:
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Never Exposed to Cladribine | All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985). | 3 | None | 10 | 198 | 26 | 198 | View |
| Exposed to Cladribine | All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985). | 5 | None | 63 | 950 | 124 | 950 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 21.0 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Brain herniation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 21.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 21.0 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 21.0 | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 21.0 | View |
| Subdural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 21.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 21.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 21.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | View |
| Intervertebral disc degeneration | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Breast cancer stage II | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Colon cancer stage 0 | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Metastases to lung | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Nonkeratinising carcinoma of nasopharynx | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Ovarian germ cell teratoma benign | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Papillary thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Polycythaemia vera | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Thyroid adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Ataxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Brain oedema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Cerebellar syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Hemiparaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Monoparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Multiple sclerosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Multiple sclerosis relapse | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Optic neuritis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Relapsing-remitting multiple sclerosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 21.0 | View |
| Abortion | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Abortion missed | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 21.0 | View |
| Neonatal anoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | View |
| Abortion induced | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 21.0 | View |
| Stem cell transplant | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 21.0 | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 21.0 | View |
| Abortion threatened | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Foetal death | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 21.0 | View |
| Dandy-Walker syndrome | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 21.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 21.0 | View |
| Vertigo positional | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 21.0 | View |
| Goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 21.0 | View |
| Thyroid mass | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 21.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 21.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 21.0 | View |
| Gastrointestinal melanosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 21.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 21.0 | View |
| Accidental death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 21.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 21.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 21.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 21.0 | View |
| Meningoencephalitis herpetic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Pneumonia viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 21.0 | View |
| Cervix carcinoma stage 0 | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Rectal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Rectal adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Rectal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Foetal distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Premature separation of placenta | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA version 21.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 21.0 | View |
| Jealous delusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 21.0 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 21.0 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 21.0 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 21.0 | View |
| Immune thrombocytopenic purpura | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 21.0 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 21.0 | View |
| Thrombocytopenic purpura | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 21.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 21.0 | View |
| Coronary artery insufficiency | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 21.0 | View |