Adverse Events Module

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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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT02276560
Description: None
Frequency Threshold: 0
Time Frame: Three months
Study: NCT02276560
Study Brief: Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neoadjuvant Cisplatin,Nab-paclitaxel Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery 0 None 0 1 1 1 View
Adjuvant Cisplatin,Nab-paclitaxel Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2 Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2 0 None 0 0 0 0 View
Cisplatin+Pemetrexed or Gemcitabine Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4 Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Taste Disturbance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Aspiration Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View