Study: NCT03763656

Adverse event: Acute Chest Syndrome (ACS) Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3, requiring hospitalisation \>7days (n=3 participants)
Frequency: 3 affected / 32 at risk

Adverse event: Acute Chest Syndrome (ACS) Grade 2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2, requiring hospitalisation \>7days
Frequency: 1 affected / 32 at risk

Adverse event: Vaso-occlusive Crisis (VOC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3, requiring hospitalisation \>7days (n=2 participants)
Frequency: 2 affected / 32 at risk

Adverse event: Anemia secondary to SCD
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3, requiring hospitalisation for oxygen therapy and blood transfusion
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 1 affected / 32 at risk

Adverse event: Neutropenia/Low ANC Count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Haematological toxicity (ANC \<1.0x10\^9/L). n=3 Grade 3 events in n=3 participants; n=4 events in n=4 participants at least possibly related. In n=3 in the 6month-1.99 year age group, associated with viral/other illness or dose titration.
Frequency: 4 affected / 32 at risk

Adverse event: Thrombocytopenia/Low Platelet Count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Haematological toxicity (Platelet \<80x10\^9/L) were \</= Grade 2. Of which n=6 events were considered possibly related (in 3 participants), with n=5 events in the 6 month-1.99 year age group, associated with viral/other illness or dose titration.
Frequency: 5 affected / 32 at risk

Adverse event: Haemoglobin (Hb) Decreased
Serious: no
Organ System: Investigations
Notes: Haematological toxicity (Hb \<4.5g/dL or 20% drop). n=1 event Grade 3 in n=1 participant; n=2 events at least possibly related in n=1 participant in the 6month-1.99 year age group.
Frequency: 2 affected / 32 at risk

Adverse event: Absolute Reticulocyte Count (ARC) Decreased
Serious: no
Organ System: Investigations
Notes: Haematological toxicity (ARC \<80x10\^9/L; unless Hb \>9.0g/dL). All events \</= Grade 2; n=2 events at least possibly related in n=1 participant in the 6month-1.99 year age group.
Frequency: 1 affected / 32 at risk

Adverse event: Red Blood Cell (RBC) Count Decreased
Serious: no
Organ System: Investigations
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 1 affected / 32 at risk

Adverse event: Gamma-Glutamyltransferase (GGT) Increased
Serious: no
Organ System: Investigations
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 1 affected / 32 at risk

Adverse event: Hematocrit (HCT) Decreased
Serious: no
Organ System: Investigations
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhoea; n=1 event at least possibly related in n=1 participant; n=4 unrelated event of mild/moderate severity in n=3 participants.
Frequency: 4 affected / 32 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 1 affected / 32 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 1 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash; n=1 at least possibly related event in n= 1 participant; n=2 unrelated events in n=2 participants of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: \*Related Treatment Emergent Adverse Event (TEAE) in Safety population (n=32). Where relatedness is defined as anything at least possibly related to the IMP.
Frequency: 2 affected / 32 at risk

Adverse event: Sickle Cell Anemia with Crisis/Vaso-Occlusive Crisis (VOC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 'SCA with crisis' interchangeable with 'Vaso-Occlusive crisis (VOC).' n=7 events were Grade 3 or above in n=4 participants and did not meet the protocol definition of SAEs; Remainder n=46 in n=14 participants were mild/moderate severity.
Frequency: 18 affected / 32 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated viral URTI; n=1 Grade 3 event in 1 participant (6months -2.99years); n=2 events in n=2 participants of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated pain in extremity; n=1 event Grade 3 in n=1 participant; n=4 events Grade \</=2 in 4 participants.
Frequency: 5 affected / 32 at risk

Adverse event: Acute Chest Syndrome (ACS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ACS events of mild/moderate severity unrelated to IMP that did not meet the protocol definition of SAE.
Frequency: 2 affected / 32 at risk

Adverse event: Hypereosinophilic syndrome
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 6 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Salivary gland enlargement
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 6 affected / 32 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 9 affected / 32 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Ulcer
Serious: no
Organ System: General disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Gingival abscess
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 5 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Tonsilitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 17 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 5 affected / 32 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Forearm fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Vitamin D decreased
Serious: no
Organ System: Investigations
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Soft tissue swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Benign rolandic epilepsy
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 4 affected / 32 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Pica
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Priapism
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Allergic respiratory disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Allergic sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 7 affected / 32 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 3 affected / 32 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Urticaria papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 2 affected / 32 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated Treatment Emergent (TEAEs) of mild/moderate severity.
Frequency: 1 affected / 32 at risk