Trial Outcomes & Findings for Tygacil Drug Use Investigation (NCT NCT01789905)
NCT ID: NCT01789905
Last Updated: 2019-02-06
Results Overview
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.
Recruitment status
COMPLETED
Target enrollment
116 participants
Primary outcome timeframe
Up until 14 days from the start date and 28 days from the end of the observation period
Results posted on
2019-02-06
Participant Flow
Participant milestones
| Measure |
Tygacil (Tigecycline)
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tygacil (Tigecycline)
n=116 Participants
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
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|---|---|
|
Age, Customized
<15 years
|
5 Participants
n=116 Participants
|
|
Age, Customized
≥15 and <65 years
|
47 Participants
n=116 Participants
|
|
Age, Customized
≥65 years
|
64 Participants
n=116 Participants
|
|
Sex/Gender, Customized
Male
|
64 Participants
n=116 Participants
|
|
Sex/Gender, Customized
Female
|
52 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: Up until 14 days from the start date and 28 days from the end of the observation periodPopulation: The safety analysis set comprised of participants who had received Tygacil at least once.
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.
Outcome measures
| Measure |
Tygacil (Tigecycline)
n=116 Participants
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Number of Participants With Adverse Drug Reaction (ADR)
ADR
|
41 Participants
|
|
Number of Participants With Adverse Drug Reaction (ADR)
Serious ADR
|
15 Participants
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SECONDARY outcome
Timeframe: Within 14 days from the start datePopulation: The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end date of the observation period at least once. Participants evaluated as "indeterminate (n=28)" were excluded from the calculation.
Clinical response rate, which was defined as the percentage of participants who achieved clinical response as "effective" over the total number of assessable effectiveness analysis population("effective" plus "ineffective",) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as "effective," "ineffective," or "indeterminate" by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings.
Outcome measures
| Measure |
Tygacil (Tigecycline)
n=116 Participants
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Clinical Response Rate
|
73.9 Percentage of Participants
Interval 63.4 to 82.7
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SECONDARY outcome
Timeframe: Within 28 days post-treatmentPopulation: The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the Test-of-Cure visit at least once. Participants evaluated as "indeterminate (n=38) " were excluded from the calculation.
The cure rate, which was defined as the percentage of participants who were assessed as "cure" over the total number of assessable effectiveness analysis population ("cure" plus "failure"), was presented along with two-sided 95% CI. Clinical response of cure was assessed as "cure," "failure," or "indeterminate" by the physician within 28 days post-treatment.
Outcome measures
| Measure |
Tygacil (Tigecycline)
n=116 Participants
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Clinical Response Rate of Cure
|
59.0 Percentage of Participants
Interval 47.3 to 70.0
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Adverse Events
Tygacil (Tigecycline)
Serious events: 49 serious events
Other events: 54 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
Tygacil (Tigecycline)
n=116 participants at risk
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
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|---|---|
|
Vascular disorders
Hypotension
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Venous thrombosis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Vascular disorders
Haemorrhage
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal impairment
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal disorder
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Seizure
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Brain oedema
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Altered state of consciousness
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Platelet count decreased
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Blood bilirubin increased
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Systemic candida
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Superinfection
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Septic shock
|
4.3%
5/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Sepsis
|
5.2%
6/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia
|
4.3%
5/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Peritonitis
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pathogen resistance
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Oral viral infection
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Oral herpes
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Mucormycosis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Fungal infection
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Encephalitis viral
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Encephalitis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Immune system disorders
Graft versus host disease
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Immune system disorders
Engraftment syndrome
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Immune system disorders
Acute graft versus host disease
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Pyrexia
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
5.2%
6/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Mucous membrane disorder
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Mucosal inflammation
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Disease progression
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Condition aggravated
|
6.0%
7/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
General disorders
Chest discomfort
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Melaena
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Eye disorders
Eye pain
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
2/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.86%
1/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
Other adverse events
| Measure |
Tygacil (Tigecycline)
n=116 participants at risk
Participants who received Tygacil as indicated in the approved local product document were observed for a period of 14 days at maximum. The follow-up period was 28 days post-treatment. The dosage can be adjusted as per physician's discretion.
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Psychiatric disorders
Delirium
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
10/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
8/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Renal and urinary disorders
Renal impairment
|
5.2%
6/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.4%
4/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Blood bilirubin increased
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
|
|
Investigations
Pancreatic enzymes increased
|
2.6%
3/116 • Up until 14 days from the start date and 28 days from the end of the observation period
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events 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