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:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
NCT ID:
NCT00961220
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected from during treatment over a 6 month time period.
Study:
NCT00961220
Study Brief:
O6-Benzylguanine and Topical Carmustine in Treating Patients With Early-Stage IA-IIA Cutaneous T-Cell 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (O6-benzylguanine, Carmustine) | Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only). laboratory biomarker analysis: Correlative studies | None | None | 0 | 17 | 16 | 17 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACNEIFORM RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| ANEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| BLOATING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| CREATININE ELEVATION | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| CUTANEOUS HYPERPIGMENTATION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| INJECTION SITE REACTION or PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| JOINT PAINS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| MONOCYTE ELEVATION | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| MYALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| PAIN OF SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| RASH/ DESQUAMATION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| TOTAL BILIRUBIN ELEVATED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| TRANSAMINASE ELEVATION | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |
| URIC ACID ELEVATION | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| URINE SPECIFIC GRAVITY ELEVATED | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| DRY SKIN | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| GLUCOSE LOW | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| LEUKOPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| SKIN ULCERATION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| TELANGIECTASIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| ALKALINE PHOSPHATASE ELEVATED | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (3.0) | View |