Trial Outcomes & Findings for The Prevent Severe COVID-19 (PRESECO) Study (NCT NCT04600895)
NCT ID: NCT04600895
Last Updated: 2024-03-29
Results Overview
The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1187 participants
Primary outcome timeframe
From Day 0 to Day 28
Results posted on
2024-03-29
Participant Flow
Participant milestones
| Measure |
Favipiravir
Favipiravir 200mg tablet
Favipiravir: Favipiravir
|
Placebo
Placebo 200mg tablet
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
599
|
588
|
|
Overall Study
ITT
|
599
|
588
|
|
Overall Study
MITT
|
599
|
588
|
|
Overall Study
MITT2
|
539
|
505
|
|
Overall Study
COMPLETED
|
480
|
462
|
|
Overall Study
NOT COMPLETED
|
119
|
126
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Prevent Severe COVID-19 (PRESECO) Study
Baseline characteristics by cohort
| Measure |
Favipiravir
n=599 Participants
Favipiravir 200mg tablet
Favipiravir: Favipiravir
|
Placebo
n=588 Participants
Placebo 200mg tablet
Placebo: Placebo
|
Total
n=1187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
543 Participants
n=93 Participants
|
544 Participants
n=4 Participants
|
1087 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
Age, Continuous
|
42 years
n=93 Participants
|
44 years
n=4 Participants
|
43 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
317 Participants
n=93 Participants
|
327 Participants
n=4 Participants
|
644 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
282 Participants
n=93 Participants
|
261 Participants
n=4 Participants
|
543 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
63 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
122 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
485 Participants
n=93 Participants
|
491 Participants
n=4 Participants
|
976 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
482 participants
n=93 Participants
|
480 participants
n=4 Participants
|
962 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
35 participants
n=93 Participants
|
30 participants
n=4 Participants
|
65 participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
82 participants
n=93 Participants
|
78 participants
n=4 Participants
|
160 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 28The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.
Outcome measures
| Measure |
Favipiravir
n=599 Participants
Favipiravir 200mg tablet
Favipiravir: Favipiravir
|
Placebo
n=588 Participants
Placebo 200mg tablet
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Sustained Clinical Recovery
|
425 Participants
|
475 Participants
|
SECONDARY outcome
Timeframe: From study day 3 to day 28Proportion of subjects with COVID-19 progression, where progression is defined as the occurrence from study day 3 onward of any emergency department (ED) visit for COVID-19 worsening or shortness of breath OR hospitalization for COVID-19 worsening or shortness of breath OR death (narrow progression)
Outcome measures
| Measure |
Favipiravir
n=599 Participants
Favipiravir 200mg tablet
Favipiravir: Favipiravir
|
Placebo
n=588 Participants
Placebo 200mg tablet
Placebo: Placebo
|
|---|---|---|
|
Proportion of Subjects With COVID-19 Progression (Narrow Progression)
|
174 Participants
|
113 Participants
|
Adverse Events
Favipiravir
Serious events: 12 serious events
Other events: 84 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 89 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Favipiravir
n=599 participants at risk
Favipiravir 200mg tablet
Favipiravir: Favipiravir
|
Placebo
n=588 participants at risk
Placebo 200mg tablet
Placebo: Placebo
|
|---|---|---|
|
Infections and infestations
Covid-19
|
2.0%
12/599 • Number of events 12 • From baseline through Day 28
|
2.4%
14/588 • Number of events 14 • From baseline through Day 28
|
Other adverse events
| Measure |
Favipiravir
n=599 participants at risk
Favipiravir 200mg tablet
Favipiravir: Favipiravir
|
Placebo
n=588 participants at risk
Placebo 200mg tablet
Placebo: Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Gastrointestinal disorders
Nausea
|
1.3%
8/599 • Number of events 8 • From baseline through Day 28
|
1.4%
8/588 • Number of events 8 • From baseline through Day 28
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
3/599 • Number of events 3 • From baseline through Day 28
|
1.4%
8/588 • Number of events 8 • From baseline through Day 28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
5/599 • Number of events 5 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
3/599 • Number of events 3 • From baseline through Day 28
|
0.68%
4/588 • Number of events 4 • From baseline through Day 28
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.33%
2/599 • Number of events 2 • From baseline through Day 28
|
0.68%
4/588 • Number of events 4 • From baseline through Day 28
|
|
Gastrointestinal disorders
Dyspepsia
|
0.33%
2/599 • Number of events 2 • From baseline through Day 28
|
0.68%
4/588 • Number of events 4 • From baseline through Day 28
|
|
Gastrointestinal disorders
Abdominal distension
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Gastrointestinal disorders
Constipation
|
0.33%
2/599 • Number of events 2 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Gastrointestinal disorders
Dysphagia
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Gastrointestinal disorders
Flatulence
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Gastrointestinal disorders
Oral pain
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Nervous system disorders
Dizziness
|
0.83%
5/599 • Number of events 5 • From baseline through Day 28
|
1.7%
10/588 • Number of events 10 • From baseline through Day 28
|
|
Nervous system disorders
Headache
|
0.67%
4/599 • Number of events 4 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Nervous system disorders
Anosmia
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.68%
4/588 • Number of events 4 • From baseline through Day 28
|
|
Nervous system disorders
Somnolence
|
0.33%
2/599 • Number of events 2 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Nervous system disorders
Burning sensation
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Nervous system disorders
Ageusia
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Nervous system disorders
Presyncope
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Nervous system disorders
Syncope
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Nervous system disorders
Tremor
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Nervous system disorders
Paraesthesia
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
7/599 • Number of events 7 • From baseline through Day 28
|
0.85%
5/588 • Number of events 5 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
4/599 • Number of events 4 • From baseline through Day 28
|
1.0%
6/588 • Number of events 6 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.50%
3/599 • Number of events 3 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.33%
2/599 • Number of events 2 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
2/599 • Number of events 2 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 2 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.17%
1/599 • Number of events 21 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 13 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/599 • Number of events 21 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.17%
1/599 • Number of events 21 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.17%
1/599 • Number of events 21 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Infections and infestations
COVID-19 pneumonia
|
1.0%
6/599 • Number of events 16 • From baseline through Day 28
|
0.85%
5/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Pneumonia
|
0.33%
2/599 • Number of events 16 • From baseline through Day 28
|
0.85%
5/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
COVID-19
|
0.50%
3/599 • Number of events 16 • From baseline through Day 28
|
0.51%
3/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Nasopharyngitis
|
0.17%
1/599 • Number of events 16 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Bronchitis
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 17 • From baseline through Day 28
|
|
Infections and infestations
Sinusitis
|
0.17%
1/599 • Number of events 16 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
General disorders
Chest discomfort
|
0.67%
4/599 • Number of events 11 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Chest pain
|
0.00%
0/599 • From baseline through Day 28
|
0.51%
3/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Hypothermia
|
0.33%
2/599 • Number of events 11 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Pyrexia
|
0.17%
1/599 • Number of events 11 • From baseline through Day 28
|
0.34%
2/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Chills
|
0.33%
2/599 • Number of events 11 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
General disorders
Pain
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Asthenia
|
0.17%
1/599 • Number of events 11 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
General disorders
Feeling hot
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Malaise
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
General disorders
Peripheral swelling
|
0.17%
1/599 • Number of events 11 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
3/599 • Number of events 6 • From baseline through Day 28
|
1.2%
7/588 • Number of events 11 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.50%
3/599 • Number of events 6 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 11 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.83%
5/599 • Number of events 10 • From baseline through Day 28
|
0.34%
2/588 • Number of events 7 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.17%
1/599 • Number of events 10 • From baseline through Day 28
|
0.51%
3/588 • Number of events 7 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.17%
1/599 • Number of events 10 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.17%
1/599 • Number of events 10 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.17%
1/599 • Number of events 10 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.17%
1/599 • Number of events 10 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.17%
1/599 • Number of events 10 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/599 • From baseline through Day 28
|
0.34%
2/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Blood uric acid increased
|
0.33%
2/599 • Number of events 6 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Investigations
Serum ferritin increased
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Blood glucose increased
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Blood potassium increased
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
C-reactive protein increased
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Heart rate increased
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Hepatic enzyme increased
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Investigations
Liver function test abnormal
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 7 • From baseline through Day 28
|
|
Investigations
Liver function test increased
|
0.17%
1/599 • Number of events 6 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.33%
2/599 • Number of events 4 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.17%
1/599 • Number of events 4 • From baseline through Day 28
|
0.17%
1/588 • Number of events 5 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 5 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 5 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 5 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
1/599 • Number of events 4 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 5 • From baseline through Day 28
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.17%
1/599 • Number of events 4 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.17%
1/599 • Number of events 5 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Ear and labyrinth disorders
Ear pain
|
0.33%
2/599 • Number of events 5 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.17%
1/599 • Number of events 5 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Ear and labyrinth disorders
Tinnitus
|
0.17%
1/599 • Number of events 5 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Ear and labyrinth disorders
Vertigo
|
0.17%
1/599 • Number of events 5 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Psychiatric disorders
Anxiety
|
0.33%
2/599 • Number of events 3 • From baseline through Day 28
|
0.34%
2/588 • Number of events 3 • From baseline through Day 28
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 3 • From baseline through Day 28
|
|
Psychiatric disorders
Restlessness
|
0.17%
1/599 • Number of events 3 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
1/599 • Number of events 2 • From baseline through Day 28
|
0.17%
1/588 • Number of events 3 • From baseline through Day 28
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.17%
1/599 • Number of events 2 • From baseline through Day 28
|
0.17%
1/588 • Number of events 3 • From baseline through Day 28
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Cardiac disorders
Sinus bradycardia
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 2 • From baseline through Day 28
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 2 • From baseline through Day 28
|
|
Renal and urinary disorders
Dysuria
|
0.17%
1/599 • Number of events 3 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Renal and urinary disorders
Pollakiuria
|
0.17%
1/599 • Number of events 3 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Renal and urinary disorders
Renal failure
|
0.17%
1/599 • Number of events 3 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Eye disorders
Eye irritation
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 2 • From baseline through Day 28
|
|
Eye disorders
Eye pain
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 2 • From baseline through Day 28
|
|
Vascular disorders
Hypertension
|
0.17%
1/599 • Number of events 1 • From baseline through Day 28
|
0.00%
0/588 • From baseline through Day 28
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/599 • From baseline through Day 28
|
0.17%
1/588 • Number of events 1 • From baseline through Day 28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place