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 @ 12:33 AM
Ignite Modification Date: 2025-12-25 @ 10:41 PM
NCT ID: NCT05104567
Description: Analysis was performed on the exposed population.
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected from first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 9 months (Cohorts A, D1 and D2), 26 months (Cohorts B1, B2 and B3) and 21 months (Cohort C). All-cause mortality (deaths) were collected from first dose of study treatment administration (Day 1) to the end of follow-up for death for each participant, up to approximately 19 months.
Study: NCT05104567
Study Brief: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A: ESCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy Participants with advanced unresectable or metastatic ESCC, regardless of PD-L1 expression (any CPS), who had received at least 1 but no more than 2 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1 based regimen were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 1 None 2 5 5 5 View
CohortB1:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS>=1:Pegenzileukin24mcg/kg+Pembrolizumab as 1-3LTherapy Participants with advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS \>=1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 16 None 17 22 20 22 View
CohortB2:GC/GEJ PD-1/PD-L1 naïve Non-MSI-H CPS<1:Pegenzileukin24 mcg/kg+Pembrolizumab as 1-3LTherapy Participants with advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had not received more than 2 prior lines of treatment that did not include an anti-PD-1/PD-L1-based regimen with the level of PD-L1 expression at baseline as CPS \<1 GC/GEJ were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 15 None 13 19 18 19 View
Cohort B3: GC/GEJ Post PD-1/PD-L1 Non-MSI-H: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2-4L Therapy Participants with advanced unresectable or metastatic GC or Siewert Type 2 \& 3 GEJ and for whom SOC was not in best interest or where no SOC was established, non-MSI-H disease and had received atleast 1 and no more than 3 prior lines of treatment and had progressed after primary or secondary resistance to an anti-PD-1/PD-L1-based regimen (regardless of the disease CPS status) were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2-4L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 12 None 9 18 17 18 View
Cohort C: HCC Post PD-1/PD-L1: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy Participants with advanced unresectable or metastatic HCC, regardless of any CPS, who relapsed on prior PD-1/PD-L1-based regimens, with at least SD as best response and with no more than 2 prior lines of treatment were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 6 None 7 20 19 20 View
Cohort D1: CRC Non-MSI-H Any RAS: Pegenzileukin 24 mcg/kg + Pembrolizumab as 3-6L Therapy Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, any RAS type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 3-6L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. 24 None 19 30 30 30 View
Cohort D2: CRC Non-MSI-H RAS Wild Type: Pegenzileukin 24 mcg/kg + Cetuximab as 3-6L Therapy Participants with advanced unresectable or metastatic CRC, regardless of any CPS, non-MSI-H disease, RAS wild type, who had progressed on prior regimens having contained fluoropyrimidine, oxaliplatin, irinotecan, with either bevacizumab or cetuximab, and with no more than 5 prior lines of treatments were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m\^2 on Cycle 1 Day 1 followed by 250 mg/m\^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 3-6L therapy) until PD. 18 None 11 24 24 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Metastases To Bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Failure To Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Immune Effector Cell-Associated Neurotoxicity Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Hypovolaemic Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Gastric Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastrointestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastrointestinal Toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Intestinal Pseudo-Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Malignant Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Small Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Ureteric Compression SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Lumbar Vertebral Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Gastric Antral Vascular Ectasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Immune-Mediated Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Jaundice Cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Pneumonia Pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 27.0 View
Congenital Rubella Syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDra 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Localised Oedema SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Candida Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Oral Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.0 View
Cancer Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 27.0 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.0 View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Eye Pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Visual Acuity Reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDra 27.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.0 View
Aphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Larynx Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Nasal Inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Respiratory Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Angular Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Haemorrhoidal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Lip Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Biliary Obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Hepatic Pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Immune-Mediated Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Dermatitis Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Dermatitis Psoriasiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Hand Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.0 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDra 27.0 View
Abnormal Loss Of Weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Mood Swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.0 View
Brain Fog SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Dyspnoea Exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.0 View
Photosensitivity Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Rash Pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Seborrhoeic Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 27.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDra 27.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.0 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.0 View