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: 2025-12-24 @ 9:26 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT05234632
Description: None
Frequency Threshold: 0
Time Frame: Adverse events for closed incisions collected 14 days post-surgery with a further 16 days follow-up period, up to 30 days from initial application of treatment. Adverse events for chronic wounds and dehisced surgical wounds were collected up to 28 days during the therapy period with no follow up.
Study: NCT05234632
Study Brief: Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PICO 14 Closed Incisions Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up. PICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film. 0 None 1 25 21 25 View
PICO 14 Chronic/Dehisced Surgical Wounds Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up. PICO 14 single-use Negative Pressure Wound Therapy System: The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film. 1 None 3 19 11 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ADMITTED TO HOSPITAL WITH A CHEST INFECTION. SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PATIENTS GENERAL HEALTH HAS QUICKLY DECLINED AND IS NOW AT END OF LIFE SYSTEMATIC_ASSESSMENT General disorders None View
PATIENT HOSPITALISED WITH CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders None View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ANAEMIA POST SURGERY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
BLISTER ON RIGHT EDGE OF ADHESIVE STRIP SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
BLISTER TO BELLY BUTTON SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
BLOOD STAINED SPUTUM SYSTEMATIC_ASSESSMENT Vascular disorders None View
BP 106/47- HYPOTENSION SYSTEMATIC_ASSESSMENT General disorders None View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CHEST INFECTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
EXTENSIVE BRUISING TO OPERATED LEG SYSTEMATIC_ASSESSMENT Vascular disorders None View
LOOSE BOWELS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LOOSE STOOL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LOOSE STOOL INCONTINENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
LOW EGFR SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
MILD CRAMPS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MILD PAIN SYSTEMATIC_ASSESSMENT General disorders None View
PAIN AROUND WOUND SITE AFTER REMOVAL OF CLIPS SYSTEMATIC_ASSESSMENT General disorders None View
PAIN CENTRAL ABDOMEN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN ON REMOVAL OF DRESSING SYSTEMATIC_ASSESSMENT General disorders None View
PAIN OPERATED SITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PASSED FRESH BLOOD PER RECTUM SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PATIENT DESCRIBES INTERMITTENT COOLING SENSATION ON FOOT OF OPERATED LEG SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PATIENT HAD COVID SYSTEMATIC_ASSESSMENT Infections and infestations None View
PATIENT PRESENTED AND TREATED FOR ONGOING EXACERBATED COPD SYMPTOMS & SUSPECTED CHEST INFECTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
WHITE CELL COUNT ELEVATED POST-OPERATIVELY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
CONGESTIVE DERMATITIS OF THE LOWER LEGS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DISTENDED ABDOMEN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRAIN SITE OOZING PUS AND RED SYSTEMATIC_ASSESSMENT General disorders None View
DRESSING STUCK TO THE WOUND AND CAUSED SOME EXCORIATION TO THE SURROUNDING SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DROWSINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ELEVATED INFLAMMATORY MARKERS SYSTEMATIC_ASSESSMENT General disorders None View
ELEVATED WHITE BLOOD CELL COUNT POST-OPERATIVELY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
EXCORIATION TO SURROUNDING SKIN TO WOUND SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
FAINT DAY 9 POST-OPERATIVELY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
FALL AT HOME- HIT HEAD SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
FEELING GENERALLY UNWELL SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
FEELING ROUGH SYSTEMATIC_ASSESSMENT General disorders None View
FRANK RECTAL BLEED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HAEMATOMA AT WOUND SITE SYSTEMATIC_ASSESSMENT Vascular disorders None View
HAEMATURIA ON CATHETER REMOVAL SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
HB 97 SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
HEADACHES SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Endocrine disorders None View
HYPOGLYCEMIA SYSTEMATIC_ASSESSMENT Endocrine disorders None View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Endocrine disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT General disorders None View
ILEOSTOMY LEAK INTO WOUND DRESSING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ILEUS SYSTEMATIC_ASSESSMENT General disorders None View
INFECTED HAEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
LEFT ELBOW PAIN. NUMBNESS TI RING & LITTLE FINGER SYSTEMATIC_ASSESSMENT General disorders None View
LOW MAGNESIUM SYSTEMATIC_ASSESSMENT Endocrine disorders None View
LOW PHOSPHATE SYSTEMATIC_ASSESSMENT Endocrine disorders None View
LOW POST-OPERATIVE SODIUM SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
LOW POTASSIUM SYSTEMATIC_ASSESSMENT Endocrine disorders None View
LOW SODIUM LEVEL SYSTEMATIC_ASSESSMENT Endocrine disorders None View
LOW TEMPERATURE SYSTEMATIC_ASSESSMENT General disorders None View
MACERATED WOUND EDGES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
MELENA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MIGRAINE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MONOCYTES: 0.9 HB: 102 WBC: 14.7 NEUTROPHILS: 11.7 CREATINE: 91 E-GFR/1.73M*2 50 SYSTEMATIC_ASSESSMENT Immune system disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NONE PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
OEDEMA- ANKLES SYSTEMATIC_ASSESSMENT General disorders None View
ON ARRIVAL WAS FOUND TO HAVE 2 X MOISTURE LESIONS TO SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
OOZING DRAIN WOUND SITE SYSTEMATIC_ASSESSMENT General disorders None View
PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAIN OPERATIVE SITE SYSTEMATIC_ASSESSMENT General disorders None View
PAIN RIGHT SIDE SYSTEMATIC_ASSESSMENT General disorders None View
PAIN VAS 6-8 IN OPERATED KNEE SYSTEMATIC_ASSESSMENT General disorders None View
PAINFUL FOOT WHEN TWISTED ANKLE DURING A FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PANIC ATTACKS SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
PARTICIPANT FINDING PICO14 DRESSING UNCOMFOTABLE, DISTURBING SLEEP SYSTEMATIC_ASSESSMENT General disorders None View
PAIN FROM COCCYX NOT WOUND SITE AS ADHESIVE STRIPS TOUCH COCCYX (PAIN IN COCCYX FROM PREVIOUS FALL) SYSTEMATIC_ASSESSMENT General disorders None View
POOR URINE OUTPUT SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
POST-OPERATIVE ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
POST-OPERATIVE ITCH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
POSTURAL DROP HYPOTENSION SYSTEMATIC_ASSESSMENT General disorders None View
PRESSURE DAMAGE TO THE DORSAL CREASE FROM STOCKING MOVEMENT AND CREASING OVER AREA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
RAISED BLOOD SUGAR 9.6 SYSTEMATIC_ASSESSMENT Endocrine disorders None View
RAISED C-REACTIVE PROTEIN SYSTEMATIC_ASSESSMENT General disorders None View
RAISED CREATININE SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RAISED POST-OPERATIVE WHITE BLOOD CELLS SYSTEMATIC_ASSESSMENT General disorders None View
RAISED RED BLOOD COUNT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
RAISED WHITE BLOOD COUNT SYSTEMATIC_ASSESSMENT Immune system disorders None View
RECTAL BLEED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
REDDEN AREA LEFT HEEL DUE TO PRESSURE, SKIN IS NOT BROKEN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
REDUCED O2 SATURATIONS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SEVERE ITCHING ON SURGICAL SITE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SKIN IRRITATION UNDER THE BANDAGE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SKIN RASH FORMED POST-OP, CLUSTERED IN DENSE LINES & AREAS OF SKIN ACROSS RIGHT-SID CHEST & SHOULDER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SLIGHT POST-OPERATIVE ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
SLUGGISH BOWEL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SMALL BOWEL LOOP OBSTRUCTION SYSTEMATIC_ASSESSMENT General disorders None View
SMALL BRUISING/DEEP TISSUE INJURY TO LEFT EDGE OF WOUND SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SORE NOSE DUE TO NASOJEJUNAL AND NASOGASTRIC TUBE SYSTEMATIC_ASSESSMENT General disorders None View
SUPERFICIAL WOUND DEHISCENE SYSTEMATIC_ASSESSMENT General disorders None View
SWELLING LOWER LEG SYSTEMATIC_ASSESSMENT General disorders None View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
TRAUMA TO WOUND BED ON REMOVAL OF DRESSING SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
TYPE 7 STOOL- DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URINE CONCENTRATED SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
VACANT EPISODE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
VASOVAGAL SYSTEMATIC_ASSESSMENT Nervous system disorders None View
VERY DIZZY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VOMITTED GREEN FLUID SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WIND LIKE UPPER ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WIND PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View