Trial Outcomes & Findings for Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients (NCT NCT02065713)
NCT ID: NCT02065713
Last Updated: 2020-11-13
Results Overview
Changes from baseline in Dactylitis Severity Score at 24 weeks. Each digit with dactylitis was evaluated in a severity scale from 0 to 3 (0 = no dactylitis; 1 = mild dactylitis, 2 = moderate dactylitis, 3 = severe dactylitis). The total score is calculated as the sum of the individual digits dactylitis scores, ranging from a minimum 0 to a maximum of 60, with higher scores corresponding to worse severities.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
From baseline to week 24
Results posted on
2020-11-13
Participant Flow
GO-DACT was a proof-of-concept multicentric, investigator-initiated trial conducted between August 2014 and June 2017, in 13 Rheumatology centres in Portugal.
Participant milestones
| Measure |
Placebo in Combination With Methotrexate
Methotrexate (MTX) started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
|
Golimumab in Combination With Methotrexate
Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo in Combination With Methotrexate
Methotrexate (MTX) started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
|
Golimumab in Combination With Methotrexate
Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
Baseline Characteristics
Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients
Baseline characteristics by cohort
| Measure |
Golimumab in Combination With Methotrexate
n=21 Participants
Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
|
Placebo in Combination With Methotrexate
n=23 Participants
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
n=5 Participants
|
44.1 years
n=7 Participants
|
45.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Dactylitis Severity Score (DSS)
|
6.0 score on a scale
n=5 Participants
|
6.0 score on a scale
n=7 Participants
|
6.0 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 24Population: An intention-to-treat analysis (ITT) was performed for the primary endpoint, applying the last observation carried forward method and including all randomly assigned patients who received at least one dose of study medication.
Changes from baseline in Dactylitis Severity Score at 24 weeks. Each digit with dactylitis was evaluated in a severity scale from 0 to 3 (0 = no dactylitis; 1 = mild dactylitis, 2 = moderate dactylitis, 3 = severe dactylitis). The total score is calculated as the sum of the individual digits dactylitis scores, ranging from a minimum 0 to a maximum of 60, with higher scores corresponding to worse severities.
Outcome measures
| Measure |
Placebo in Combination With Methotrexate
n=23 Participants
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
|
Golimumab in Combination With Methotrexate
n=21 Participants
Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
|
|---|---|---|
|
Dactylitis Severity Score (DSS)
|
-2 change of score on a scale
Interval -3.75 to -1.0
|
-5 change of score on a scale
Interval -9.0 to -3.5
|
Adverse Events
Placebo in Combination With Methotrexate
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Golimumab in Combination With Methotrexate
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo in Combination With Methotrexate
n=23 participants at risk
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
|
Golimumab in Combination With Methotrexate
n=21 participants at risk
Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
Other adverse events
| Measure |
Placebo in Combination With Methotrexate
n=23 participants at risk
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Placebo: The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
|
Golimumab in Combination With Methotrexate
n=21 participants at risk
Golimumab 50mg, subcutaneous, once monthly, for 24 weeks, in combination with MTX.
MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
Golimumab: Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
Methotrexate: MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Blood and lymphatic system disorders
Macrocytosis
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Cardiac disorders
Hypertension
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Number of events 3 • For 32 weeks
|
9.5%
2/21 • Number of events 3 • For 32 weeks
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Gastrointestinal disorders
Anal haemorrhage
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
General disorders
Influenza-like illness
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
General disorders
Febrile infection
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
General disorders
Cough
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Hepatobiliary disorders
Transaminases increased
|
17.4%
4/23 • Number of events 5 • For 32 weeks
|
14.3%
3/21 • Number of events 3 • For 32 weeks
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Immune system disorders
Cutaneovisceral angiomatosis with thrombocytopenia
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
14.3%
3/21 • Number of events 3 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Number of events 2 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Renal and urinary disorders
Hyperuricaemia
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Renal and urinary disorders
Cystitis
|
4.3%
1/23 • Number of events 2 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Reproductive system and breast disorders
Genital candidiasis
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • For 32 weeks
|
9.5%
2/21 • Number of events 2 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
13.0%
3/23 • Number of events 4 • For 32 weeks
|
9.5%
2/21 • Number of events 2 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Viral rhinitis
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
4.8%
1/21 • Number of events 2 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.00%
0/23 • For 32 weeks
|
9.5%
2/21 • Number of events 2 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Viral pharyngitis
|
8.7%
2/23 • Number of events 2 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/23 • For 32 weeks
|
9.5%
2/21 • Number of events 2 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection viral
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Latent tuberculosis
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema eyelids
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.7%
2/23 • Number of events 2 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Oral herpes
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
9.5%
2/21 • Number of events 2 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/23 • For 32 weeks
|
14.3%
3/21 • Number of events 3 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Haematoma
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Surgical and medical procedures
Tooth extraction
|
13.0%
3/23 • Number of events 3 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Cervicalgia
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Gingivitis
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Herpetic gingivostomatitis
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Stomatitis aphthous
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Pain
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Skin and subcutaneous tissue disorders
Molluscum contagiosum
|
4.3%
1/23 • Number of events 1 • For 32 weeks
|
0.00%
0/21 • For 32 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/23 • For 32 weeks
|
4.8%
1/21 • Number of events 1 • For 32 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place