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 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
NCT ID:
NCT02167451
Description:
None
Frequency Threshold:
0
Time Frame:
day+ 100 after BMT or 30 days after last maraviroc administration if patients withdrew from study
Study:
NCT02167451
Study Brief:
Maraviroc as GVHD Prophylaxis in Transplant Recipients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Maraviroc | Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73). Maraviroc | 4 | None | 11 | 31 | 16 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection- Disseminated Adenoviremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection- Enterobacter Aerogenes Baceteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection-Enterococcus Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection-Citrobacter and Klebsiella Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection- Klebsiella Pneumonia Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection- Staphylococcus Aureus Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection- CMV Viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Immune System Other (Engraftment Syndrome) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pneumonitis due to CMV | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Colonic hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Sinusoidal Obstructive Syndrome | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| TMA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Allergic Reaction (Angioedema) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Blood Bilirubin- Increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Altered mental status | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| TMA/HUS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Sinusoidal Obstructive Syndrome | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Allergic reaction to Ambisome | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Anaphylaxis to Cyclosporine | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| CMV viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| catheter related infection ( MSSA bacteremia, staph aureus and bacillus) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Adenovirus in stool | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Adenovirus in blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| BK viremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Moraxella nonliquefaciens infection in blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| HHV6 blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Streptococcus infection in blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Klebsiella oxytoca infection in blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Candida in blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Escherichia Coli in blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| WBC decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| ALT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| AST increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |