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 @ 6:46 PM

Ignite Modification Date: 2025-12-25 @ 4:17 PM

NCT ID: NCT04101357

Description: All-cause mortality analysis was performed on all enrolled participants. All SAEs and Non-Serious AEs data collected through-out the study are reported in the AE section and analysis was performed on safety analysis set (that is, all participants who received at least one dose of BNT411).

Frequency Threshold: 0

Time Frame: From Baseline until 60 days after the last dose of study treatment (3 years and 11 months)

Study: NCT04101357

Study Brief: Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Part 1A: BNT411 Monotherapy: Dose Level (DL) 1: 0.05 mcg/kg	Participants received BNT411 at a starting dose of 0.05 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AEs, withdrawal of consent, lost to follow-up or death whichever occurs first.	1	None	1	2	2	2	View
Part 1A: BNT411 Monotherapy: DL6: 4.8 mcg/kg	Participants received BNT411 at a dose of 4.8 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	11	None	5	14	14	14	View
Part 1A: BNT411 Monotherapy: DL6_1i: 7.2 mcg/kg	Participants received BNT411 at a dose of 7.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	4	None	4	6	6	6	View
Part 1A: BNT411 Monotherapy: DL2: 0.15 mcg/kg	Participants received BNT411 at a dose of 0.15 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	1	None	0	1	1	1	View
Part 1A: BNT411 Monotherapy: DL3: 0.45 mcg/kg	Participants received BNT411 at a dose of 0.45 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	1	None	1	1	1	1	View
Part 1A: BNT411 Monotherapy: DL4: 1.2 mcg/kg	Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	2	None	1	3	3	3	View
Part 1A: BNT411 Monotherapy: DL5: 2.4 mcg/kg	Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	4	None	1	4	4	4	View
Part 1A: BNT411 Monotherapy: DL6_2i: 6.0 mcg/kg	Participants received BNT411 at a dose of 6.0 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	4	None	3	8	8	8	View
Part 1A: BNT411 Monotherapy: DL7: 9.6 mcg/kg	Participants received BNT411 at a dose of 9.6 mcg/kg as an IV infusion once a week in a 3-week cycle for the first 4 cycles (on Days 1, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 1) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	5	None	4	6	6	6	View
Part 1B: BNT411 Combination Dose: DL4: 1.2 mcg/kg	Participants received BNT411 at a dose of 1.2 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first.	2	None	2	3	3	3	View
Part 1B: BNT411 Combination Dose: DL5: 2.4 mcg/kg	Participants received BNT411 at a dose of 2.4 mcg/kg as an IV infusion in combination with atezolizumab, carboplatin and etoposide once a week in a 3-week cycle for the first 4 cycles (on Days 2, 8, and 15; each cycle duration=21 days) followed by once every 3 weeks (on Day 2) from Cycle 5 onwards until progressive disease, unacceptable AE, withdrawal of consent, lost to follow-up or death whichever occurs first	3	None	3	4	4	4	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Dyspnoea exertional	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Superior vena cava syndrome	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Tumour thrombosis	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Cerebrovascular accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysarthria	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Immune effector cell-associated neurotoxicity syndrome	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Mental status changes	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oesophagitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Disease progression	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hepatic failure	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Cytokine release syndrome	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
COVID-19	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Pancytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Diplopia	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Leukopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Atrioventricular block first degree	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Myopericarditis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Blepharitis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Cataract	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Dry eye	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eye irritation	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eye pruritus	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Meibomian gland dysfunction	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Retinal exudates	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Retinal haemorrhage	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Vision blurred	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Visual field defect	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Visual impairment	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Vitreous detachment	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Abdominal discomfort	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal distension	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain lower	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Ascites	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dry mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Flatulence	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal disorder	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haematemesis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haemorrhoidal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Lip dry	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Axillary pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Energy increased	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Face oedema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Gait disturbance	SYSTEMATIC_ASSESSMENT	General disorders	None	View
General physical health deterioration	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Generalised oedema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Influenza like illness	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Malaise	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Non-cardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hepatic pain	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Hyperbilirubinaemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Cytokine release syndrome	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Drug hypersensitivity	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
COVID-19	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cystitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Herpes simplex reactivation	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lower respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Nasopharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Oesophageal candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Oral candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Oral herpes	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Joint injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Activated partial thromboplastin time prolonged	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Amylase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Bacterial test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood calcium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood fibrinogen decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood lactate dehydrogenase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood potassium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood potassium increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood thyroid stimulating hormone increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
C-reactive protein increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Gamma-glutamyltransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
International normalised ratio increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Liver function test increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lymphocyte count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Respiratory rate increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Troponin I increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cell count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cells urine positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Decreased appetite	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Coccydynia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Flank pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Groin pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Lumbar spinal stenosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscle spasms	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Brain fog	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hemiparesis	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Lethargy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Neurotoxicity	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Paraesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral sensory neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Sleep disorder	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Social avoidant behaviour	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Chromaturia	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Dysuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Micturition urgency	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Nocturia	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Oliguria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Pollakiuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Proteinuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary tract obstruction	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Erectile dysfunction	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea exertional	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Increased upper airway secretion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleuritic pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Rhinitis allergic	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Tachypnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Wheezing	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Alopecia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Hyperhidrosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Night sweats	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash maculo-papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash pruritic	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Deep vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Embolism	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Flushing	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View