Trial Outcomes & Findings for Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency (NCT NCT02199496)
NCT ID: NCT02199496
Last Updated: 2020-08-24
Results Overview
Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
6 months
Results posted on
2020-08-24
Participant Flow
Participant milestones
| Measure |
Cohort 1: Single-dose Phase 1, Multi-dose Phase 2
Subjects given single dose of 270mg Ustekinumab subcutaneously then re-enrolled into the multi-dose phase. In multi-dose phase subjects given single dose of 270mg Ustekinumab subcutaneously with follow up treatment doses of 90 mg (1 dose of 90 mg) at week 8, week 16, week 24, week 32, and week 40
|
Cohort 2: Multi-Dose Ustekinumab Phase 2
Subjects given single dose of 270mg Ustekinumab subcutaneously then follow up treatment doses of 90 mg (1 dose of 90 mg) at week 8, week 16, week 24, week 32, and week 40
|
|---|---|---|
|
Ustekinumab-Single Dose
STARTED
|
3
|
0
|
|
Ustekinumab-Single Dose
COMPLETED
|
3
|
0
|
|
Ustekinumab-Single Dose
NOT COMPLETED
|
0
|
0
|
|
Ustekinumab-Multi-dose
STARTED
|
3
|
2
|
|
Ustekinumab-Multi-dose
COMPLETED
|
3
|
2
|
|
Ustekinumab-Multi-dose
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency
Baseline characteristics by cohort
| Measure |
Cohort 1: Ustekinumab-Single-dose Phase 1, Multi-dose Phase 2
n=3 Participants
Subjects given an induction dose of 270 mg Stelara (ustekinumab) subcutaneously then re-enrolled into the multi-dose phase. In multi-dose phase, subjects given an induction dose of 270 mg Stelara (ustekinumab) subcutaneously followed by every 8 week maintenance doses of 90 mg Stelara (ustekinumab) subcutaneously at week 8, week 16, week 24, week 32, and week 40
|
Cohort 2: Ustekinumab-Multi-dose Phase 2
n=2 Participants
Subjects given an induction dose of 270 mg Stelara (ustekinumab) subcutaneously followed by every 8 week maintenance doses of 90 mg Stelara (ustekinumab) subcutaneously at week 8, week 16, week 24, week 32, and week 40
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants who received ustekinumab
Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events
Outcome measures
| Measure |
Cohort 1: Ustekinumab-Single Dose Phase 1
n=3 Participants
Single dose of 270mg ustekinumab subcutaneously
|
|---|---|
|
Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Single Dose Administration of Ustekinumab
|
0 participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Participants who received ustekinumab
Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events
Outcome measures
| Measure |
Cohort 1: Ustekinumab-Single Dose Phase 1
n=3 Participants
Single dose of 270mg ustekinumab subcutaneously
|
|---|---|
|
Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 1)
|
0 participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Participants who received ustekinumab
Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events
Outcome measures
| Measure |
Cohort 1: Ustekinumab-Single Dose Phase 1
n=2 Participants
Single dose of 270mg ustekinumab subcutaneously
|
|---|---|
|
Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 2)
|
0 participants
|
Adverse Events
Cohort 1: Ustekinumab-Single Dose Phase 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: Ustekinumab-Multi-dose Phase 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Ustekinumab-Multi-dose Phase 2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Ustekinumab-Single Dose Phase 1
n=3 participants at risk
Single dose of 270mg ustekinumab subcutaneously
|
Cohort 1: Ustekinumab-Multi-dose Phase 2
n=3 participants at risk
Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
|
Cohort 2: Ustekinumab-Multi-dose Phase 2
n=2 participants at risk
Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
Other adverse events
| Measure |
Cohort 1: Ustekinumab-Single Dose Phase 1
n=3 participants at risk
Single dose of 270mg ustekinumab subcutaneously
|
Cohort 1: Ustekinumab-Multi-dose Phase 2
n=3 participants at risk
Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
|
Cohort 2: Ustekinumab-Multi-dose Phase 2
n=2 participants at risk
Single dose of 270mg ustekinumab subcutaneously then follow up doses of 90 mg ustekinumab subcutaneously at week 8, week 16, week 24, week 32, and week 40
|
|---|---|---|---|
|
Investigations
Prothrombin time prolonged
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Norovirus test positive
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Blood and lymphatic system disorders
Lymph node pain
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
3/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
2/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Chest pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Chills
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Fatigue
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Injection site pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Malaise
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Oedema
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Swelling
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
General disorders
Tenderness
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
2/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Enterovirus infection
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
3/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Infections and infestations
Upper respiratory tract infection
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Injury, poisoning and procedural complications
Injury
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Alpha-1 anti-trypsin increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood 1,25-dihydroxycholecalciferol increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood chloride increased
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood copper decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood glucose decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
2/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood lactate dehydrogenase
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Blood zinc decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Clostridium test positive
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Epstein-Barr virus test positive
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Faecal calprotectin increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Faecal fat increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
False positive investigation result
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Haematocrit decreased
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Vitamin B6 increased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
Weight decreased
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
3/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
100.0%
3/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Vitamin B6 deficiency
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Metabolism and nutrition disorders
Vitamin E deficiency
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Carpal tunnel syndrome
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
66.7%
2/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Reproductive system and breast disorders
Breast mass
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
33.3%
1/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
0.00%
0/3 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
50.0%
1/2 • 6 months for Phase 1 and 48 Weeks for Phase 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place