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 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT02425306
Description:
The study will be monitored continuously for treatment-related adverse events.
A DLT is defined as any unexpected adverse event that is possibly, probably or definitely related to treatment and meets the following criteria:
* ≥ Grade 3
* ≥ Grade 1 ocular adverse events as defined below
* ≥ Grade 2 allergic/autoimmune reactions as defined below Exceptions are made for small vaccine site ulceration, and for some transient systemic AEs.
Frequency Threshold:
5
Time Frame:
Through administration of the last dose of 6MHP or mCy, plus 30 days. The scheduled dosing was designed such that the last does of 6MHP vaccine was to be given on day 78 and that the last dose of mCy was to be given on day 57. Thus, for a participant treated on schedule, and to completion, the AE period was 108 days. However, if either or both agents were given for a shorter period (eg held for toxicity), then the time period may be shorter.
Study:
NCT02425306
Study Brief:
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
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 A:6MHP + Montanide ISA-51 | Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. 6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant | 0 | None | 0 | 3 | 3 | 3 | View |
| Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide | Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days: * Day -6 (Cycle 1) * Day 8 (Cycle 2) * Day 22 (Cycle 3) * Day 36 (Cycle 4) * Day 50 (Cycle 5) 6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant Cyclophosphamide: Cyclophosphamide, systemic adjuvant | 0 | None | 1 | 7 | 7 | 7 | View |
| Arm C:6MHP + polyICLC + Montanide ISA-51 | Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. 6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant polyICLC: polyICLC, local adjuvant | 0 | None | 0 | 6 | 6 | 6 | View |
| Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide | Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days: * Day -6 (Cycle 1) * Day 8 (Cycle 2) * Day 22 (Cycle 3) * Day 36 (Cycle 4) * Day 50 (Cycle 5) 6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant polyICLC: polyICLC, local adjuvant Cyclophosphamide: Cyclophosphamide, systemic adjuvant | 0 | None | 0 | 32 | 32 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Skin induration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Mucositis, oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |