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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
NCT ID:
NCT02954458
Description:
None
Frequency Threshold:
5
Time Frame:
From start of study drug administration up to follow-up (up to 46 months)
Study:
NCT02954458
Study Brief:
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | Participants who participated in standard of care arm in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks. | 0 | None | 2 | 3 | 3 | 3 | View |
| Teduglutide /Non-teduglutide Treatment (TED/NTT) | Participants who received teduglutide in the core study TEDC14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study. | 0 | None | 1 | 1 | 1 | 1 | View |
| Teduglutide/Teduglutide Treatment (TED/TED) | Participants who received teduglutide in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks. | 2 | None | 41 | 50 | 50 | 50 | View |
| Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | Participants who participated in standard of care arm in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study. | 0 | None | 4 | 7 | 6 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial thrombosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Colonic haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Enterocutaneous fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Ileus paralytic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Intestinal dilatation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Mallory-Weiss syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Complication associated with device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Condition aggravated | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Granuloma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Staphylococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Escherichia test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Device expulsion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 19.1 | View |
| Adenovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Arthritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Device related sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Escherichia bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastroenteritis astroviral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastroenteritis clostridial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastrointestinal bacterial overgrowth | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Hand-foot-and-mouth disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Infectious mononucleosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Malassezia infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Overgrowth bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pneumonia viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pulmonary mycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Rotavirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Abdominal wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Postoperative ileus | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Vascular access complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Astrovirus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Bacterial test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood culture positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Enterovirus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Failure to thrive | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Feeding intolerance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hyperchloraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hypernatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Lactic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Tenosynovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Cerebral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Device breakage | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Renal tubular acidosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Tubulointerstitial nephritis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Hypocapnia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Superior vena cava occlusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Vena cava thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Small intestinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.1 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abnormal faeces | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Anal incontinence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Frequent bowel movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Catheter site discharge | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Catheter site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Catheter site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Complication associated with device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Medical device site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Drug-induced liver injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastrointestinal bacterial overgrowth | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Malassezia infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Abdominal wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Anastomotic ulcer | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Gastrointestinal stoma complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Gastrostomy tube site complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Post procedural discomfort | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Soft tissue injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Stoma site reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood 25-hydroxycholecalciferol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood bicarbonate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Carcinoembryonic antigen increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Crystal urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Gastrointestinal stoma output increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Prothrombin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| White blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hyperchloraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Tenosynovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Device breakage | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Learning disability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Rash erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Catheter removal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 19.1 | View |