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 @ 12:07 PM
Ignite Modification Date:
2025-12-25 @ 11:58 AM
NCT ID:
NCT02047461
Description:
All-cause Mortality is zero in this study because there were no deaths that occurred.
All SAE data is included
Frequency Threshold:
0
Time Frame:
Adverse event data were collected from Day 1 with ORGN001 treatment until Month 24 for all patients; additional data included for patients treated up to Month 90
Study:
NCT02047461
Study Brief:
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Patients Currently Receiving rcPMP Infusions at Baseline and Transitioned to ORGN001 | Patients currently receiving rcPMP infusions at baseline are transitioned to ORGN001 (formerly ALXN1101), starting at their current rcPMP dose and escalating to a target dose of 0.9 mg/kg. | 0 | None | 8 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Complication associated with device | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Vascular device infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Retching | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Teething | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Catheter site discharge | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site discoloration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Complication associated with device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Medical device site discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Swelling face | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Blister infected | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Bronchitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Bullous impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Catheter site abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Ear infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Eye infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Pneumonia influenzal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Pustule | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Viral tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Muscle injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Post procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Postoperative respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Scar | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Tendon injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Traumatic haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.0) | View |
| Blood iron decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Culture urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Heart rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Procalcitonin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Vitamin D decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.0) | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.0) | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.0) | View |
| Metabolic alkalosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.0) | View |
| Type 1 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.0) | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Foot deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Growth retardation | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Joint contracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Kyphoscoliosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Kyphosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | View |
| Pyogenic granuloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | View |
| Cerebral atrophy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Dystonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Hypertonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Muscle spasticity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Opisthotonos | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Tonic convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.0) | View |
| Device leakage | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.0) | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.0) | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.0) | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.0) | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.0) | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.0) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Asthmatic crisis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Bronchopneumopathy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Increased upper airway secretion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Lung disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Obstructive sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Pneumonitis aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Upper airway obstruction | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Keratosis pilaris | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Livedo reticularis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Purpura | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.0) | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.0) | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.0) | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.0) | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.0) | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.0) | View |
| Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (25.0) | View |
| Tympanic membrane hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (25.0) | View |
| Chalazion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.0) | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.0) | View |
| Eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.0) | View |
| Eye swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.0) | View |
| Strabismus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Barrett's oesophagus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Erosive oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Gastrointestinal motility disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Gastroesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Mouth haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Noninfective gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |