Trial Outcomes & Findings for A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting (NCT NCT00488488)
NCT ID: NCT00488488
Last Updated: 2011-07-22
Results Overview
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Recruitment status
COMPLETED
Target enrollment
1028 participants
Primary outcome timeframe
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Results posted on
2011-07-22
Participant Flow
Non-interventional study; participants were selected and treated according to the usual clinical practice of their physician.
A total of 1,028 participants were documented at 137 observational sites. Three participants were excluded from analysis due to retrospective documentation.
Participant milestones
| Measure |
Tygacil
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Overall Study
STARTED
|
1028
|
|
Overall Study
Analyzed
|
1025
|
|
Overall Study
COMPLETED
|
760
|
|
Overall Study
NOT COMPLETED
|
268
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
Baseline characteristics by cohort
| Measure |
Tygacil
n=1025 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Age Continuous
|
64.4 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
380 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
642 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing Data (Unspecified)
|
3 participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Pseudomonas aeruginosa (n=23)
|
73.9 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Proteus vulgaris (n=3)
|
33.3 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Proteus mirabilis (n=6)
|
16.7 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Other pathogens (unspecified) (n=30)
|
13.3 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Enterobacter species (spp) (n=26)
|
3.8 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Klebsiella pneumoniae (n=29)
|
3.4 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Enterococcus faecalis (n=65)
|
1.5 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Escherichia coli (n=99)
|
1.0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Enterococcus faecium (n=146)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Staphylococcus aureus (n=120)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Staphylococcus spp (n=63)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Klebsiella oxytoca (n=16)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Stenotrophomonas maltophilia (n=8)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Streptococcus pyogenes (A group) (n=7)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Other clostridiae (n=6)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Citrobacter freundii (n=5)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Streptococcus anginosus group (n=5)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Other Bacteroides species (n=5)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Acinetobacter spp. (n=4)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Bacteroides fragilis (n=3)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Haemophilus spp (n=2)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Streptococcus pneumoniae (n=2)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Peptostreptococcus (n=2)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Serratia spp (n=1)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Morganella morganii (n=1)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Bacteroides thetaiotamicron (n=1)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Streptococcus agalactiae (B group) (n=1)
|
0 percentage of participants
n=5 Participants
|
|
Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens
Clostridium perfringens (n=1)
|
0 percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)Population: All participants: participants exposed to Tygacil who had non-retrospective post-baseline data.
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Outcome measures
| Measure |
Tygacil
n=1025 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Clinical and Microbiological Cure: All Participants
|
33.8 percentage of participants
Interval 30.9 to 36.7
|
PRIMARY outcome
Timeframe: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)Population: All participants; N = number of participants with nosocomial infections.
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Outcome measures
| Measure |
Tygacil
n=658 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections
|
29.0 percentage of participants
Interval 25.6 to 32.7
|
PRIMARY outcome
Timeframe: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)Population: All participants; N = number of participants with community-acquired infections.
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Outcome measures
| Measure |
Tygacil
n=344 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections
|
43.9 percentage of participants
Interval 38.6 to 49.3
|
PRIMARY outcome
Timeframe: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)Population: All participants.
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Outcome measures
| Measure |
Tygacil
n=1025 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Composite Cure: All Participants
|
74.2 percentage of participants
|
PRIMARY outcome
Timeframe: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)Population: All participants; N = number of participants with nosocomial infections.
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Outcome measures
| Measure |
Tygacil
n=658 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Composite Cure: Nosocomial Infections
|
70.5 percentage of participants
|
PRIMARY outcome
Timeframe: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)Population: All participants; N = number participants with community-acquired infections.
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Outcome measures
| Measure |
Tygacil
n=344 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Composite Cure: Community-acquired Infections
|
82.3 percentage of participants
|
SECONDARY outcome
Timeframe: Follow-up (up to Day 47)Population: All participants.
Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Outcome measures
| Measure |
Tygacil
n=1025 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Participants With Probable Failure at Follow-up
|
162 participants
|
SECONDARY outcome
Timeframe: Follow-up (up to Day 47)Population: All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance.
Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Outcome measures
| Measure |
Tygacil
n=162 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Pseudomonas aeruginosa (n=12)
|
100.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Other pathogens (unspecified) (n=6)
|
100.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Klebsiella oxytoca (n=1)
|
100.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Proteus mirabilis (n=6)
|
50.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Proteus vulgaris (n=2)
|
50.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Stenotrophomonas maltophilia (n=4)
|
25.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Klebsiella pneumoniae (n=9)
|
22.2 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Enterococcus faecalis (n=10)
|
20.0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Enterobacter species (spp) (n=11)
|
18.2 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Escherichia coli (n=14)
|
7.1 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Staphylococcus aureus (n=16)
|
6.3 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Enterococcus faecium (n=15)
|
0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Staphylococcus spp (n=5)
|
0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Serratia spp (n=2)
|
0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Citrobacter freundii (n=1)
|
0 percentage of participants
|
|
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Acinetobacter spp. (n=1)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to Day 47)Population: All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil.
Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
Outcome measures
| Measure |
Tygacil
n=512 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
ceftazidime (n=191)
|
18.6 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
ciprofloxacin (n=62)
|
6.0 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
fluconazole (n=59)
|
5.8 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
meropenem (n=49)
|
4.8 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
metronidazole (n=48)
|
4.7 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
vancomycin (n=27)
|
2.6 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
cefepime (n=26)
|
2.5 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
pip/tazo (n=18)
|
1.8 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
piperacillin (n=14)
|
1.4 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
caspofungin (n=13)
|
1.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
levofloxacin (n=13)
|
1.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
other antimycotics for system use (n=13)
|
1.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
imipenem (n=12)
|
1.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
primaxin (n=12)
|
1.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
voriconazole (n=11)
|
1.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
erythromycin (n=10)
|
1.0 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
gentamicin (n=10)
|
1.0 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
sulbactam (n=10)
|
1.0 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
tobramycin (n=10)
|
1.0 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
clarithromycin (n=9)
|
0.9 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
moxifloxacin (n=9)
|
0.9 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
aciclovir (n=7)
|
0.7 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
clindamycin (n=7)
|
0.7 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
other beta-lactam antibacterials (n=5)
|
0.5 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
ampicillin (n=4)
|
0.4 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
fosfomycin (n=4)
|
0.4 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
linezolid (n=4)
|
0.4 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
amikacin (n=3)
|
0.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
amphotericin B (n=3)
|
0.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
bactrim (n=3)
|
0.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
flucloxacillin (n=3)
|
0.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
rifampicin (n=3)
|
0.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
unacid (n=3)
|
0.3 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
benzylpenicillin (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
beta-lactam antibacterials, penicillins (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
ceftriaxone (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
colistin (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
doxycycline (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
ganciclovir (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
tazobactam (n=2)
|
0.2 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
amoxi-clavulanico (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
antibiotics (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
azithromycin (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
cefotaxime (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
cefuroxime (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
chloramphenicol (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
clemizole penicillin (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
penicillin not otherwise specified (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
piperacillin with tazobactam (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
teicoplanin (n=1)
|
0.1 percentage of participants
|
|
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
tienam (n=1)
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to Day 47)Population: All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible.
Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
Outcome measures
| Measure |
Tygacil
n=191 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Other (de-escalation) (n=80)
|
7.8 percentage of participants
|
|
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
No clinical response (n=71)
|
6.9 percentage of participants
|
|
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Microbiological resistance (n=26)
|
2.5 percentage of participants
|
|
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Oral treatment continuation (n=14)
|
1.4 percentage of participants
|
|
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Intolerability (n=5)
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to Day 47)Population: All participants; n = number of participants with specified reason for utilization of Tygacil.
Outcome measures
| Measure |
Tygacil
n=1025 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Reasons for Utilization of Tygacil
Failure on previous antibiotic treatment (n=549)
|
53.6 percentage of participants
|
|
Reasons for Utilization of Tygacil
Suspicion of resistant pathogens (n=470)
|
45.9 percentage of participants
|
|
Reasons for Utilization of Tygacil
Broad efficacy spectrum (n=463)
|
45.2 percentage of participants
|
|
Reasons for Utilization of Tygacil
Primary (n=114)
|
11.1 percentage of participants
|
|
Reasons for Utilization of Tygacil
Intolerability to previous antibiotic (n=21)
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to Day 47)Population: All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections.
Deaths for any reasons occurring during the study observation period.
Outcome measures
| Measure |
Tygacil
n=1025 Participants
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
Overall Mortality: All Participants
|
20.0 percentage of participants
Interval 17.6 to 22.6
|
Adverse Events
Tygacil
Serious events: 245 serious events
Other events: 155 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tygacil
n=1025 participants at risk
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
General disorders
Multi-organ failure
|
10.2%
105/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
4.6%
47/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug ineffective
|
2.1%
22/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Concomitant disease progression
|
1.1%
11/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
0.59%
6/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
General physical health deterioration
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Death
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Brain death
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease recurrence
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug resistance
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
6.8%
70/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic shock
|
3.4%
35/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.88%
9/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candida sepsis
|
0.59%
6/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pseudomonas infection
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Aspergillosis
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Catheter related infection
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterococcal infection
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal sepsis
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abscess
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candidiasis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Catheter sepsis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Empyema
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Endocarditis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterobacter infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterococcal sepsis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fusarium infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gangrene
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Liver abscess
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pathogen resistance
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic embolus
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Streptococcal sepsis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
14/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary disease
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.98%
10/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
8/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.49%
5/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Left ventricular failure
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.49%
5/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.4%
14/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholestasis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
13/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.59%
6/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
C-reactive protein increased
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count increased
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood urea increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Ammonia increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Antithrombin III decreased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Procalcitonin increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Circulatory collapse
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Shock
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Shock haemorrhagic
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Brain stem ischaemia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraplegia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Laparotomy
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Tygacil
n=1025 participants at risk
Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
|
|---|---|
|
General disorders
Drug ineffective
|
5.5%
56/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.68%
7/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
0.49%
5/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug effect decreased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug resistance
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
General physical health deterioration
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Impaired healing
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Inflammation
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema due to cardiac disease
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pathogen resistance
|
1.4%
14/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candidiasis
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacterial disease carrier
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candida pneumonia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Catheter sepsis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterococcal infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterococcal sepsis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Escherichia infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Intestinal fistula infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Morganella infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritoneal candidiasis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia escherichia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Proteus infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pseudomonas infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Skin infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Soft tissue infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Splenic abscess
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Streptococcal infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.49%
5/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Prothrombin time prolonged
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
C-reactive protein increased
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood urea increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Lipase increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count increased
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood cholesterol increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Clostridium difficile toxin test positive
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Interleukin level increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count increased
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.68%
7/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
6/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
4/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.68%
7/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.29%
3/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephritis interstitial
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Vesical fistula
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.20%
2/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.10%
1/1025
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER