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 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
NCT ID:
NCT03348904
Description:
All treated participants.
Frequency Threshold:
5
Time Frame:
From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
Study:
NCT03348904
Study Brief:
Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung 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 |
|---|---|---|---|---|---|---|---|---|
| Nivolumab + Epacadostat/Platinum Doublet Chemotherapy | Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. | 0 | None | 0 | 0 | 0 | 0 | View |
| Platinum Doublet Chemotherapy | Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. | 1 | None | 1 | 2 | 2 | 2 | View |
| Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy | Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.0 | View |