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 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
NCT ID:
NCT03077451
Description:
Among 36 participants, 31 participants received the high dose of nelfinavir after receiving the standard dose of nelfinavir.
Mortality report was based on all 36 participants. For mortality report in high dose was based on 31 participants which is a subset of 36 participants.
Adverse Event and Serious Adverse Event reports were based on 36 participants treated with standard dose levels of nelfinavir and 31 participants treated with high dose after standard dose.
Frequency Threshold:
5
Time Frame:
8 weeks (4 weeks for standard dose and 4 weeks for high dose);
Study:
NCT03077451
Study Brief:
Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | This study is not parallel arm study. Nelfinavir dose will be administrated in the sequential manner according to the response. AE summary is based on participants who received high dose. There were totally 31 participants received high dose after receiving standard dose. All patients will received standard dose of nelfinavir (1250 mg BID) for at least 4 weeks. If after 4 weeks there is progressive disease (PD), the participant will advance to the high dose nelfinavir (3125 mg BID). If by 8 weeks there is stable disease (SD) or partial response (PR) at the standard dose, the participant will advance to high dose of nelfinavir. The high dose nelfinavir treatment will be continued for at least 4 weeks. If there is progressive disease (PD) documented after 4 weeks at the high dose level, nelfinavir will be discontinued. If there is stable disease (SD) or partial response (PR) at the high dose level, high dose nelfinavir will be continued for up to 16 weeks. If there is a complete response (CR), high dose treatment will be discontinued 4 weeks after documentation of complete response. | 0 | None | 1 | 31 | 28 | 31 | View |
| Standard Dose Treatment (Nelfinavir Mesylate) | This study is not parallel arm study. Nelfinavir dose will be administrated in the sequential manner according to the response. AE summary is based on participants who received standard dose. There were totally 36 participants received standard dose initally. All patients will received standard dose of nelfinavir (1250 mg BID) for at least 4 weeks. If there is complete response (CR) at any time at the standard dose, nelfinavir will be discontinued 4 weeks after documentation of CR. | 0 | None | 0 | 36 | 5 | 36 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| HYPERGLYCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| HYPERTRIGLYCERIDEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| EDEMA LIMBS | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| FEVER | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| LOCALIZED EDEMA | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| HERPES SIMPLEX REACTIVATION | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| INVESTIGATIONS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| WHITE BLOOD CELL DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| HYPONATREMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| TUMOR PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| SORE THROAT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | None | View |