TriangleNCT00866918 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Not reported
- Other-event reporting threshold
- 0%
Patients who were study ineligible (n=6) or inevaluable (n=1, RQ-PCR negative at diagnosis) were excluded from number at risk in the Serious and Other Adverse event data tables.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Standard Risk | 17 / 66 | 61 / 66 | Not reported / Not reported |
| High Risk | 14 / 35 | 33 / 35 | Not reported / Not reported |
Serious adverse events
- notes
- Adeers submitted
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Abdominal pain
- notes
- Adeers submitted
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Acidosis
- notes
- Adeers submitted
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Adult respiratory distress syndrome
- notes
- Adeers submitted
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Alanine aminotransferase increased
- notes
- Adeers submitted
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Anorexia
- notes
- Adeers submitted
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Aspartate aminotransferase increased
- notes
- Adeers submitted
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Asystole
- notes
- Adeers submitted
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Blood bilirubin increased
- notes
- Adeers submitted
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Bronchial infection
- notes
- Adeers submitted
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 35
- term
- Catheter related infection
- notes
- Adeers submitted
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Dehydration
- notes
- Adeers submitted
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Depression
Other reported adverse events
- notes
- Adeers not subm
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 35
- term
- Abdominal pain
- notes
- Adeers not subm
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Acidosis
- notes
- Adeers not subm
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Activated partial thromboplastin time prolonged
- notes
- Adeers not subm
- organ System
- Renal and urinary disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Acute kidney injury
- notes
- Adeers not subm
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Adult respiratory distress syndrome
- notes
- Adeers not subm
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Agitation
- notes
- Adeers not subm
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 35
- term
- Alanine aminotransferase increased
- notes
- Adeers not subm
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Alkaline phosphatase increased
- notes
- Adeers not subm
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Allergic reaction
- notes
- Adeers not subm
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Anal pain
- notes
- Adeers not subm
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Anemia
- notes
- Adeers not subm
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Anorectal infection
Complete source fields
- description
- Patients who were study ineligible (n=6) or inevaluable (n=1, RQ-PCR negative at diagnosis) were excluded from number at risk in the Serious and Other Adverse event data tables.
- event Groups
- description
- WBC\<10,000/MicroLiter
- id
- EG000
- other Num Affected
- 61
- other Num At Risk
- 66
- serious Num Affected
- 17
- serious Num At Risk
- 66
- title
- Standard Risk
- description
- WBC\>=10,000/MicroLiter
- id
- EG001
- other Num Affected
- 33
- other Num At Risk
- 35
- serious Num Affected
- 14
- serious Num At Risk
- 35
- title
- High Risk
- frequency Threshold
- 0
- other Events
- notes
- Adeers not subm
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 35
- term
- Abdominal pain
- notes
- Adeers not subm
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Acidosis
- notes
- Adeers not subm
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Activated partial thromboplastin time prolonged
- notes
- Adeers not subm
- organ System
- Renal and urinary disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Acute kidney injury
- notes
- Adeers not subm
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Adult respiratory distress syndrome
- notes
- Adeers not subm
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Agitation
- notes
- Adeers not subm
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 35
- term
- Alanine aminotransferase increased
- notes
- Adeers not subm
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Alkaline phosphatase increased
- notes
- Adeers not subm
- organ System
- Immune system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Allergic reaction
- notes
- Adeers not subm
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Anal pain
- notes
- Adeers not subm
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Anemia
- notes
- Adeers not subm
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Anorectal infection
- serious Events
- notes
- Adeers submitted
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Abdominal pain
- notes
- Adeers submitted
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Acidosis
- notes
- Adeers submitted
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 35
- term
- Adult respiratory distress syndrome
- notes
- Adeers submitted
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Alanine aminotransferase increased
- notes
- Adeers submitted
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Anorexia
- notes
- Adeers submitted
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Aspartate aminotransferase increased
- notes
- Adeers submitted
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Asystole
- notes
- Adeers submitted
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Blood bilirubin increased
- notes
- Adeers submitted
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 35
- term
- Bronchial infection
- notes
- Adeers submitted
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 35
- term
- Catheter related infection
- notes
- Adeers submitted
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Dehydration
- notes
- Adeers submitted
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 66
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 35
- term
- Depression
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