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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00278408
Description:
Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5.
The number analyzed differs from overall number analyzed due to missing data.
Frequency Threshold:
0
Time Frame:
Each patient will be observed for at least 3 years starting from completion of treatment.
Study:
NCT00278408
Study Brief:
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication | Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate | 7 | None | 17 | 81 | 49 | 81 | View |
| Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication | Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim | 7 | None | 17 | 81 | 58 | 81 | View |
| Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication | Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate | 15 | None | 43 | 155 | 98 | 155 | View |
| Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication | Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim | 11 | None | 41 | 150 | 82 | 150 | View |
| Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication | Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate | 10 | None | 30 | 114 | 41 | 114 | View |
| Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication | Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim | 11 | None | 27 | 114 | 65 | 114 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Life-threatening infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Severe Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| secondary neoplasia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| unplanned hospitalisation (emergency case) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia CTC 3, 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Nausea CTC 3-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting CTC 3-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoe CTC 3-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Arrhythmia CTC 3-5 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac functions CTC 3-5 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sensory CTC 3-5 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Infection CTC 3-5 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Constipation CTC 3-5 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mucositis CTC 3-5 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Mood CTC 3-5 | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Allergy CTC 3-5 | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Leukocytopenia CTC 3, 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia CTC 3, 4 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |