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 @ 3:35 PM
Ignite Modification Date:
2025-12-25 @ 1:47 PM
NCT ID:
NCT00068692
Description:
Group 1 patients received concurrent chemotherapy and radiation in step 1, and then received the adjuvant therapy in step 2 after randomization. Adverse events were reported for step 1 (arm S) and step 2 (arms I,II,III) separately. Group 2 patients were registered and randomized at the same time, and adverse events for adjuvant therapy were reported at step 2 (arms I, II, III).
Frequency Threshold:
5
Time Frame:
Assessed at the end of every cycle (1 cycle=2 weeks for Arm I and Arm II in both groups, 1 cycle=8 weeks for Arm III in both groups) while on treatment and for 30 days after the end of treatment, assessed up to 10 years
Study:
NCT00068692
Study Brief:
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm S | Preoperative chemo/radiation therapy received by Group I patients in step 1 | 1 | None | 62 | 123 | 27 | 123 | View |
| Group I, Arm I | Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV | 8 | None | 11 | 27 | 7 | 27 | View |
| Group I, Arm II | Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed immediately by fluorourcil IV bolus on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV | 12 | None | 14 | 22 | 3 | 22 | View |
| Group I, Arm III | Patients receive 1 of 3 preoperative chemo and radiotherapy treatment regimens, determined by the treating physician. Within 21-56 days after the completion of chemoradiotherapy, patients undergo surgical resection. Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 8 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV | 11 | None | 10 | 28 | 3 | 28 | View |
| Group II, Arm I | Patients receive irinotecan, leucovorin calcium, and fluorouracil as in group 1, arm I for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity. Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Irinotecan: Given IV | 11 | None | 21 | 31 | 6 | 31 | View |
| Group II, Arm II | Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in group 1, arm II for 4 courses. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity. Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Given IV | 9 | None | 23 | 33 | 6 | 33 | View |
| Group II, Arm III | Patients receive leucovorin calcium and fluorouracil as in group 1, arm III for 1 course. Within 4 weeks after the completion of chemotherapy, all patients undergo concurrent pelvic chemoradiotherapy as described in group 1 preoperative chemo and radiotherapy Regimen A, B, or C, followed 4-6 weeks later by 4 additional courses of adjuvant chemotherapy for arms I and II and 2 additional courses of adjuvant chemotherapy for arm III. Treatment continues in the absence of disease progression or unacceptable toxicity. Radiotherapy: Undergo external beam radiation therapy Fluorouracil: Given IV Leucovorin Calcium: Given IV | 10 | None | 23 | 32 | 12 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 3.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Leukocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Neutrophils decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Platelets decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Hematologic-other | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Cardiac-ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Fever w/o neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Radiation dermatitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Hand-foot reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Incontinence, anal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Leak, incl. anastomotic, rectum | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Muco/stomatitis by exam, oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis by exam, pharynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis (symptom) oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis (symptom) pharynx | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis (symptom) rectum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Obstruction, colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Obstruction, small bowel NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| GI-other | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Surgical hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Infection w/ gr3-4 neut, abdomen NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection w/ gr3-4 neut, pelvis NOS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection w/ gr3-4 neut, urinary tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, abdomen | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, catheter | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, penis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, rectum | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, wound | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection w/ unk ANC rectum | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection w/ unk ANC blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Metabolic/Laboratory-other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Nonneuropathic generalized weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Back, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Extremity-limb, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Neck, pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Neuropathic, pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Oral cavity, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Pain NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Rectum, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Throat/pharynx/larynx, pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Urethra, pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 3.0 | View |
| Pain-other | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Hiccoughs | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Incontinence urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 3.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE 3.0 | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Leukocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Neutrophils decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Platelets decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Hand-foot reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis by exam, oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis (symptom) oral cavity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |