Trial Outcomes & Findings for Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater (NCT NCT00359632)
NCT ID: NCT00359632
Last Updated: 2015-06-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
Through and including 28 calendar days after the last administration of the investigational product
Results posted on
2015-06-26
Participant Flow
Nine centers (2 centers in Italy, 1 center in Sweden, and 6 centers in the US) enrolled subjects for inclusion in the study. Sites were selected based on their capability to perform the comprehensive testing and to treat types of infections that might require therapy with linezolid for 6 weeks or longer.
There were separate selection criteria for subjects in the treated and control groups. At the Screening/Baseline visit (Day 1), subjects were eligible for the study after verification that they met the relevant inclusion/exclusion criteria and the study had been explained to them.
Participant milestones
| Measure |
Linezolid
Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
9
|
|
Overall Study
COMPLETED
|
20
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Linezolid
Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Non-compliance with visit schedule
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater
Baseline characteristics by cohort
| Measure |
Linezolid
n=24 Participants
Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
n=9 Participants
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 Years
STANDARD_DEVIATION 13.38 • n=99 Participants
|
50.1 Years
STANDARD_DEVIATION 11.86 • n=107 Participants
|
52.5 Years
STANDARD_DEVIATION 12.89 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through and including 28 calendar days after the last administration of the investigational productOutcome measures
| Measure |
Linezolid
n=24 Participants
Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
n=9 Participants
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event
Adverse events, %
|
83.3 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event
Serious adverse events, %
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event
Severe adverse events, %
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event
Discontinued due to adverse events, %
|
29.2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Adverse Event
Dose Reduced or Temporary Discontinuation, %
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At End of Study visitClinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.
Outcome measures
| Measure |
Linezolid
n=21 Participants
Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
|---|---|---|
|
Percentage of Participants by Clinical Outcome of Infection at End of Study
Cure, %
|
47.6 Percentage of Participants
|
—
|
|
Percentage of Participants by Clinical Outcome of Infection at End of Study
Improvement, %
|
42.9 Percentage of Participants
|
—
|
|
Percentage of Participants by Clinical Outcome of Infection at End of Study
Failure, %
|
0 Percentage of Participants
|
—
|
|
Percentage of Participants by Clinical Outcome of Infection at End of Study
Unknown, %
|
0 Percentage of Participants
|
—
|
|
Percentage of Participants by Clinical Outcome of Infection at End of Study
Other, %
|
9.5 Percentage of Participants
|
—
|
Adverse Events
Linezolid
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Linezolid
n=24 participants at risk
Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
n=9 participants at risk
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
|---|---|---|
|
Blood and lymphatic system disorders
Erythropoiesis abnormal
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Sideroblastic anaemia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
General physical health deterioration
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Polyneuropathy
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Linezolid
n=24 participants at risk
Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
|
Control
n=9 participants at risk
Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
6/24 • Number of events 6 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Diabetic retinal oedema
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Narrow anterior chamber angle
|
0.00%
0/24 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Optic neuropathy
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal disorder
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Toxic optic neuropathy
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tooth discolouration
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 3 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Folliculitis
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood lactic acid increased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hepatic enzyme increased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count increased
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein total increased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Vitamin B1 decreased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Vitamin B12 decreased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
12.5%
3/24 • Number of events 3 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin B6 deficiency
|
8.3%
2/24 • Number of events 2 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
3/24 • Number of events 3 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Polyneuropathy
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sinus headache
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9 • Through and including 28 calendar days after the last administration of the investigational product
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place