Study: NCT03300466

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Implant site mass
Serious: no
Organ System: General disorders
Notes: Related to study product or injection procedure. Both events in the NLF treated with GP0045.
Frequency: 1 affected / 10 at risk

Adverse event: Eye allergy
Serious: no
Organ System: Eye disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study product/study product injection
Frequency: 3 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 2 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 5 affected / 10 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Overweight
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to study product/study product injection
Frequency: 3 affected / 10 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Oral disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to study product or injection procedure. One event in right NLF (treated with comparator) and one event in left NLF (treated with GP0045).
Frequency: 1 affected / 10 at risk

Adverse event: Implant site erythema
Serious: no
Organ System: General disorders
Notes: Related to study product or injection procedure. One event in right NLF (treated with comparator) and one event in left NLF (treated with GP0045).
Frequency: 1 affected / 10 at risk

Adverse event: Implant site hypoaesthesia
Serious: no
Organ System: General disorders
Notes: Related to study product or injection procedure. In left NLF (treated with GP0045).
Frequency: 1 affected / 10 at risk

Adverse event: Implant site mass
Serious: no
Organ System: General disorders
Notes: Related to study product or injection procedure. Both events in the NLF treated with GP0045.
Frequency: 1 affected / 10 at risk

Adverse event: Implant site pain
Serious: no
Organ System: General disorders
Notes: Related to study product/injection. 9 events (5 participants) in the NLF treated with GP0045, 8 events (4 participants) in the NLF treated with comparator. (1 participant can report one event in left NLF and one event in right NLF at the same time.)
Frequency: 7 affected / 10 at risk

Adverse event: Implant site papules
Serious: no
Organ System: General disorders
Notes: Related to study product or injection procedure. In the NLF treated with GP0045.
Frequency: 1 affected / 10 at risk

Adverse event: Implant site pruritus
Serious: no
Organ System: General disorders
Notes: Related to study product or injection procedure. One event in the NLF treated with GP0045 and one event in the NLF treated with comparator.
Frequency: 1 affected / 10 at risk

Adverse event: Implant site swelling
Serious: no
Organ System: General disorders
Notes: Related to study product/injection. 9 events (3 participants) in NLF treated with GP0045, 2 events (2 participants) in the NLF treated with comparator. (1 participant can report 1 event in the right NLF and 1 event in the left NLF at the same time).
Frequency: 4 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Gingival recession
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Nodule
Serious: no
Organ System: General disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Cholangitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 7 affected / 10 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study product/study product injection
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to study product/study product injection
Frequency: 4 affected / 10 at risk