Trial Outcomes & Findings for Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV (NCT NCT00802854)
NCT ID: NCT00802854
Last Updated: 2018-11-21
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Recruitment status
COMPLETED
Target enrollment
244 participants
Primary outcome timeframe
From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis
Results posted on
2018-11-21
Participant Flow
Participant milestones
| Measure |
Eraxis
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Overall Study
STARTED
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244
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Overall Study
COMPLETED
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244
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
Baseline characteristics by cohort
| Measure |
Eraxis
n=244 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Age, Customized
Less than (<) 30 years
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6 Participants
n=5 Participants
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Age, Customized
30-39 years
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19 Participants
n=5 Participants
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Age, Customized
40-49 years
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26 Participants
n=5 Participants
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Age, Customized
50-64 years
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84 Participants
n=5 Participants
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Age, Customized
Greater than or equal to (>=) 65 years
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109 Participants
n=5 Participants
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Sex: Female, Male
Female
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107 Participants
n=5 Participants
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Sex: Female, Male
Male
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137 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Safety analysis set included all participants who received at least 1 dose of Eraxis.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Eraxis
n=244 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
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141 Participants
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
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102 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Safety analysis set included all participants who received at least 1 dose of Eraxis.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Eraxis
n=244 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
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8 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Subset of safety analysis set which included all participants who had at least 1 AE.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE.
Outcome measures
| Measure |
Eraxis
n=141 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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Duration of Adverse Events (AEs)
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4.03 days
Standard Deviation 5.81
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Safety analysis set included all participants who received at least 1 dose of Eraxis.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Outcome measures
| Measure |
Eraxis
n=244 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Number of Adverse Events (AEs) by Severity
Mild
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33 events
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Number of Adverse Events (AEs) by Severity
Moderate
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43 events
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Number of Adverse Events (AEs) by Severity
Severe
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109 events
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Subset of safety analysis set which included all participants who had at least 1 AE.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved).
Outcome measures
| Measure |
Eraxis
n=141 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Number of Participants With Outcome in Response to Adverse Events (AEs)
Yes
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106 Participants
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Number of Participants With Outcome in Response to Adverse Events (AEs)
Unknown
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7 Participants
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Number of Participants With Outcome in Response to Adverse Events (AEs)
No, resolved
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28 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Safety analysis set included all participants who received at least 1 dose of Eraxis.
AE=any untoward medical occurrence attributed to study drug in participant who received study drug. Treatment-emergent AE=AE between first dose of study drug up to 28 days after last dose that were absent before treatment/worsened relative to pretreatment state. Relatedness of AE to treatment assessed by physician as:Certain=clinically reasonable reaction on cessation of treatment;Probable/likely=followed reasonable time sequence from administration of treatment which was not explained by other drug/chemical substance/accompanying disease;Possible=followed reasonable time sequence from administration of treatment;Unlikely=not likely to have reasonable causal relationship with treatment, seems temporary;Conditional/unclassified=needed more data to make appropriate assessment/its additional data were being reviewed;Unaccessible/unclassifiable=lack of sufficient information hampered accurate causality assessment. % of AEs=(Number of AEs for specified categories/total number of AEs)\*100.
Outcome measures
| Measure |
Eraxis
n=185 AEs
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Certain
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1.08 percentage of AEs
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Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Probable/likely
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0 percentage of AEs
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Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Possible
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5.95 percentage of AEs
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Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Unlikely
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92.43 percentage of AEs
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Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Conditional/unclassified
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0 percentage of AEs
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Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)
Unaccessible/unclassifiable
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0.54 percentage of AEs
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Safety analysis set included all participants who received at least 1 dose of Eraxis. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator.
Outcome measures
| Measure |
Eraxis
n=240 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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Number of Participants With Laboratory Abnormalities
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35 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.
CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up.
Outcome measures
| Measure |
Eraxis
n=199 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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Number of Participants With Clinical Response (CR)
Cure
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88 Participants
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Number of Participants With Clinical Response (CR)
Improvement
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89 Participants
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Number of Participants With Clinical Response (CR)
Failure
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19 Participants
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Number of Participants With Clinical Response (CR)
Unevaluable
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3 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.
In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site.
Outcome measures
| Measure |
Eraxis
n=199 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Number of Participants With Mycological Response (MR)
Eradication
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149 Participants
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Number of Participants With Mycological Response (MR)
Presumed eradication
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28 Participants
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Number of Participants With Mycological Response (MR)
Persistence
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16 Participants
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Number of Participants With Mycological Response (MR)
Presumed persistence
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6 Participants
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Number of Participants With Mycological Response (MR)
Unevaluable
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0 Participants
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Number of Participants With Mycological Response (MR)
Superinfection
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0 Participants
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PRIMARY outcome
Timeframe: From the time of first dosing of Eraxis until 28 calendar days after last dose of EraxisPopulation: Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.
OR: final effectiveness evaluation analyzed using following criteria (based on physician's evaluation of CR \& MR): a)Effective:clinical success (cure/improvement) \& microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR \& MR \& neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist \& CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection.
Outcome measures
| Measure |
Eraxis
n=199 Participants
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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Number of Participants With Overall Response (OR)
Effective
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173 Participants
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Number of Participants With Overall Response (OR)
Ineffective
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26 Participants
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Number of Participants With Overall Response (OR)
Unevaluable
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0 Participants
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Adverse Events
Eraxis
Serious events: 102 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eraxis
n=244 participants at risk
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
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|---|---|
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General disorders
MULTIPLE ORGAN FAILURE
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2.9%
7/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
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Cardiac disorders
CARDIAC FAILURE
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0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
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Cardiac disorders
SHOCK
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0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
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Nervous system disorders
BRAIN HYPOXIA
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0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
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Nervous system disorders
MENINGOENCEPHALITIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
GI HAEMORRHAGE
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
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Cardiac disorders
CARDIAC ARREST
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
FIBRILLATION VENTRICULAR
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
TACHYCARDIA VENTRICULAR
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
COMA HEPATIC
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
ENDOCARDITIS
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CARCINOMA
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GI NEOPLASM MALIGNANT
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CARCINOMA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREAS NEOPLASM MALIGNANT
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PULMONARY CARCINOMA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CARCINOMA
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
INFECTION BACTERIAL
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
CANDIDIASIS
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
PERITONITIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
SEPSIS
|
18.4%
45/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
3.3%
8/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS SYNDROME
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Other adverse events
| Measure |
Eraxis
n=244 participants at risk
Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
|
|---|---|
|
General disorders
FEVER
|
2.5%
6/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
MEDICINE INEFFECTIVE
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
HYPERTENSION
|
1.6%
4/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
HYPOTENSION
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
CONVULSIONS
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
SPINAL STENOSIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
AMYLASE INCREASED
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
COLITIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
COLITIS PSEUDOMEMBRANOUS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGIC
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
GI HAEMORRHAGE
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
ILEUS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
MELAENA
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
NAUSEA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
FIBRILLATION ATRIAL
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
BILIRUBINAEMIA
|
2.5%
6/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
GAMMA-GT INCREASED
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
SGOT INCREASED
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Hepatobiliary disorders
SGPT INCREASED
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
LIPASE INCREASED
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Metabolism and nutrition disorders
PHOSPHATASE ALKALINE INCREASED
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
DELIRIUM
|
1.2%
3/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
DEPRESSION
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Psychiatric disorders
INSOMNIA
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
ABSCESS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
HERPES NOS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
INFECTION AGGRAVATED
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
INFECTION BACTERIAL
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
INFECTION FUNGAL
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
SEPSIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
DECUBITUS ULCER
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
MEDICATION ERROR
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
SKIN INFECTION
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Renal and urinary disorders
AZOTAEMIA
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Vascular disorders
THROMBOSIS
|
0.41%
1/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Eye disorders
RETINITIS
|
0.82%
2/244
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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious 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