Trial Outcomes & Findings for GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1) (NCT NCT02352974)

NCT ID: NCT02352974

Last Updated: 2020-04-27

Results Overview

Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: Month 1
• Results posted on: 2020-04-27

Participant Flow

Participant milestones

Measure	GAD-Alum+Vitamin D GAD(Glutamic acid decarboxylase)-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Main Study STARTED	12
Main Study COMPLETED	12
Main Study NOT COMPLETED	0
Extension STARTED	3
Extension COMPLETED	3
Extension NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Age, Categorical <=18 years	4 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	18.8 years STANDARD_DEVIATION 4.2 • n=12 Participants
Sex: Female, Male Female	4 Participants n=12 Participants
Sex: Female, Male Male	8 Participants n=12 Participants
Region of Enrollment Sweden	12 participants n=12 Participants
Weight	64.0 kg STANDARD_DEVIATION 13.6 • n=12 Participants
BMI	21.1 kg/m^2 STANDARD_DEVIATION 3.8 • n=12 Participants
Type 1 diabetes duration	65.1 days STANDARD_DEVIATION 55.1 • n=12 Participants
GADA (Antibodies to GAD with molecular mass 65,000)	4067.1 U/mL^2 STANDARD_DEVIATION 8491.6 • n=12 Participants
Weighted C-peptide	0.55 nmol/L STANDARD_DEVIATION 0.19 • n=12 Participants
90-minute C-peptide	0.67 nmol/L STANDARD_DEVIATION 0.19 • n=12 Participants
Fasting C-peptide	0.27 nmol/L STANDARD_DEVIATION 0.08 • n=12 Participants
HbA1c	67.17 mmol/mol STANDARD_DEVIATION 28.17 • n=12 Participants
Average insulin dose/kg/24 h	0.40 IU STANDARD_DEVIATION 0.20 • n=12 Participants
IDAA1c	9.91 IU/kg/day STANDARD_DEVIATION 3.10 • n=12 Participants

PRIMARY outcome

Timeframe: Month 1

Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Number of Subjects With Injection Site Reactions Month 1 Erythema	0 Participants
Number of Subjects With Injection Site Reactions Month 1 Oedema	0 Participants
Number of Subjects With Injection Site Reactions Month 1 Haematoma	0 Participants
Number of Subjects With Injection Site Reactions Month 1 Tenderness	1 Participants
Number of Subjects With Injection Site Reactions Month 1 Pain	0 Participants
Number of Subjects With Injection Site Reactions Month 1 Itching	0 Participants
Number of Subjects With Injection Site Reactions Month 1 Other	0 Participants

PRIMARY outcome

Timeframe: Month 2

Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Number of Subjects With Injection Site Reactions Month 2 Erythema	0 Participants
Number of Subjects With Injection Site Reactions Month 2 Oedema	0 Participants
Number of Subjects With Injection Site Reactions Month 2 Haematoma	0 Participants
Number of Subjects With Injection Site Reactions Month 2 Tenderness	1 Participants
Number of Subjects With Injection Site Reactions Month 2 Pain	0 Participants
Number of Subjects With Injection Site Reactions Month 2 Itching	0 Participants
Number of Subjects With Injection Site Reactions Month 2 Other	0 Participants

PRIMARY outcome

Timeframe: Month 3

Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Number of Subjects With Injection Site Reactions Month 3 Erythema	0 Participants
Number of Subjects With Injection Site Reactions Month 3 Oedema	0 Participants
Number of Subjects With Injection Site Reactions Month 3 Haematoma	0 Participants
Number of Subjects With Injection Site Reactions Month 3 Tenderness	2 Participants
Number of Subjects With Injection Site Reactions Month 3 Pain	0 Participants
Number of Subjects With Injection Site Reactions Month 3 Itching	0 Participants
Number of Subjects With Injection Site Reactions Month 3 Other	0 Participants

PRIMARY outcome

Timeframe: Month 32, extension period

Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Number of Subjects With Injection Site Reactions Month 32 Erythema	0 Participants
Number of Subjects With Injection Site Reactions Month 32 Oedema	0 Participants
Number of Subjects With Injection Site Reactions Month 32 Haematoma	0 Participants
Number of Subjects With Injection Site Reactions Month 32 Tenderness	0 Participants
Number of Subjects With Injection Site Reactions Month 32 Pain	0 Participants
Number of Subjects With Injection Site Reactions Month 32 Itching	0 Participants
Number of Subjects With Injection Site Reactions Month 32 Other	0 Participants

SECONDARY outcome

Timeframe: Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose

Change from baseline to month 15 in C-peptide AUC (Area Under the Curve) (mean 120min) value

AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15	-0.11 nmol/L Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose

Change from baseline to month 30 in C-peptide AUC(mean 120min) value

AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in C-peptide AUC(Mean 120min) Value, Month 30	-0.22 nmol/L Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose

Change from baseline to month 43 in C-peptide AUC(mean 120min) value

AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in C-peptide AUC(Mean 120min) Value, Month 43	-0.13 nmol/L Standard Deviation 0.05

SECONDARY outcome

Timeframe: Baseline to month 15

Change from baseline to month 15 in C-peptide 90-minute value

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in C-peptide 90-minute Value, Month 15	-0.16 nmol/L Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline to month 30

Change from baseline to month 30 in C-peptide 90-minute value

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in C-peptide 90-minute Value, Month 30	-0.29 nmol/L Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline to month 43, extension period

Change from baseline to month 43 in C-peptide 90-minute value

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in C-peptide 90-minute Value, Month 43	-0.16 nmol/L Standard Deviation 0.03

SECONDARY outcome

Timeframe: Baseline to month 15

Change from baseline to month 15 in fasting C-peptide value

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in Fasting C-peptide Value, Month 15	-0.03 nmol/L Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline to month 30

Change from baseline to month 30 in fasting C-peptide value

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in Fasting C-peptide Value, Month 30	-0.10 nmol/L Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline to month 43, extension period

Change from baseline to month 43 in fasting C-peptide value

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in Fasting C-peptide Value, Month 43	-0.07 nmol/L Standard Deviation 0.04

SECONDARY outcome

Timeframe: Baseline to month 15

Change from baseline to month 15 in HbA1c

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in HbA1c, Month 15	-14.25 mmol/mol Standard Deviation 18.91

SECONDARY outcome

Timeframe: Baseline to month 30

Change from baseline to month 30 in HbA1c

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in HbA1c, Month 30	-10.67 mmol/mol Standard Deviation 18.67

SECONDARY outcome

Timeframe: Baseline to month 43, extension period

Change from baseline to month 43 in HbA1c

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean Change in HbA1c, Month 43	-30.67 mmol/mol Standard Deviation 21.22

SECONDARY outcome

Timeframe: Baseline

External insulin dose at baseline

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
External Insulin Dose, Baseline	0.36 IU/kg/day Standard Deviation 0.13

SECONDARY outcome

Timeframe: Month 15

External insulin dose at month 15

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
External Insulin Dose, Month 15	0.34 IU/kg/day Standard Deviation 0.20

SECONDARY outcome

Timeframe: Month 30

External insulin dose at month 30

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
External Insulin Dose, Month 30	0.44 IU/kg/day Standard Deviation 0.22

SECONDARY outcome

Timeframe: Month 43, extension period

External insulin dose at month 43

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
External Insulin Dose, Month 43	0.25 IU/kg/day Standard Deviation 0.02

SECONDARY outcome

Timeframe: Baseline

Insulin dose-adjusted HbA1c (IDAA1c)

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean IDAA1c Values, Baseline	9.00 IU/kg/day Standard Deviation 1.89

SECONDARY outcome

Timeframe: Month 15

Insulin dose-adjusted HbA1c (IDAA1c)

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean IDAA1c Values, Month 15	7.64 IU/kg/day Standard Deviation 0.99

SECONDARY outcome

Timeframe: Month 30

Insulin dose-adjusted HbA1c (IDAA1c)

Outcome measures

Measure	GAD-Alum+Vitamin D n=12 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean IDAA1c Values, Month 30	8.36 IU/kg/day Standard Deviation 1.28

SECONDARY outcome

Timeframe: Month 43, extension period

Insulin dose-adjusted HbA1c (IDAA1c)

Outcome measures

Measure	GAD-Alum+Vitamin D n=3 Participants GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Mean IDAA1c Values, Month 43	7.11 IU/kg/day Standard Deviation 0.93

Adverse Events

GAD-Alum+Vitamin D

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GAD-Alum+Vitamin D n=12 participants at risk GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D
Eye disorders Retinopathy	16.7% 2/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Abdominal pain upper	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Bowel movement irregularity	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Dysphagia	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Food poisoning	16.7% 2/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Gastritis	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Toothache	8.3% 1/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Gastrointestinal disorders Nausea	16.7% 2/12 • Number of events 3 • During main study period (baseline to month 30) and extension (month 37 and 43)
General disorders Fatigue	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
General disorders Injection site pain	8.3% 1/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
General disorders Injection site reaction	8.3% 1/12 • Number of events 3 • During main study period (baseline to month 30) and extension (month 37 and 43)
General disorders Pyrexia	8.3% 1/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Immune system disorders Seasonal allergy	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Gastroenteritis	16.7% 2/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Influenza	16.7% 2/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Nasopharyngitis	75.0% 9/12 • Number of events 35 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Pneumonia	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Rhinitis	8.3% 1/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Sinusitis	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Tooth infection	8.3% 1/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Infections and infestations Viral infection	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Injury, poisoning and procedural complications Concussion	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Injury, poisoning and procedural complications Contusion	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Injury, poisoning and procedural complications Fibula fracture	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Injury, poisoning and procedural complications Joint dislocation	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Injury, poisoning and procedural complications Skin injury	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Investigations Hepatic enzyme increased	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Musculoskeletal and connective tissue disorders Plantar fascilitis	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Psychiatric disorders Anxiety	16.7% 2/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Psychiatric disorders Attention deficit/hyperactivity disorder	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Psychiatric disorders Autism spectrum disorder	16.7% 2/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Psychiatric disorders Panic disorder	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Psychiatric disorders Sleep disorder	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • Number of events 2 • During main study period (baseline to month 30) and extension (month 37 and 43)
Skin and subcutaneous tissue disorders Eczema	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Skin and subcutaneous tissue disorders Ingrowing nail	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Skin and subcutaneous tissue disorders Skin irritation	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Skin and subcutaneous tissue disorders Urticaria	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)
Vascular disorders Hypotension	8.3% 1/12 • Number of events 1 • During main study period (baseline to month 30) and extension (month 37 and 43)

Additional Information

Åsa Carlsheimer

4Pharma AB

Phone: +4672244516

Email: asa.carlsheimer@4pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place