Trial Outcomes & Findings for Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment (NCT NCT01072539)

Last Updated: 2023-12-29

Results Overview

All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.

Recruitment status

COMPLETED

Target enrollment

3172 participants

Primary outcome timeframe

From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.

Results posted on

2023-12-29

Participant Flow

Participants were enrolled between May 2010 and April 2015 from Korean health care centers.

Participant milestones

Participant milestones
Measure	Tygacil Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Overall Study STARTED	3172
Overall Study COMPLETED	3169
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tygacil Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Overall Study Treated prior to the Site Initiation	1
Overall Study Protocol Violation	2

Baseline Characteristics

Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tygacil n=3169 Participants Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Age, Customized <30 years	126 Participants n=5 Participants
Age, Customized 30 to 39 years	200 Participants n=5 Participants
Age, Customized 40 to 49 years	346 Participants n=5 Participants
Age, Customized 50 to 64 years	1116 Participants n=5 Participants
Age, Customized >=65 years	1381 Participants n=5 Participants
Sex: Female, Male Female	1089 Participants n=5 Participants
Sex: Female, Male Male	2080 Participants n=5 Participants
Infection Site cSSSI	976 Participants n=5 Participants
Infection Site cIAI	1947 Participants n=5 Participants
Infection Site CAP	242 Participants n=5 Participants
Infection Site cIAI + cSSSI	2 Participants n=5 Participants
Infection Site cIAI + CAP	2 Participants n=5 Participants
Severity of Infection Mild	287 Participants n=5 Participants
Severity of Infection Moderate	2072 Participants n=5 Participants
Severity of Infection Severe	810 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Tygacil n=3169 Participants Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs AEs	32.98 Percentage of Participants
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs ADRs	9.85 Percentage of Participants
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs SAEs	13.22 Percentage of Participants
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs SADRs	0.13 Percentage of Participants
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs Unexpected AEs	8.24 Percentage of Participants
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs Unexpected ADRs	0.44 Percentage of Participants

PRIMARY outcome

Population: Safety Analysis Set.

Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (\<65 years or \>=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.

Outcome measures

Outcome measures
Measure	Tygacil n=3169 Participants Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Prospectively Collected Data	34.15 Percentage of Participants Interval 30.73 to 37.57
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Retrospectively Collected Data	32.62 Percentage of Participants Interval 30.76 to 34.48
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Geriatric: <65 Years	30.98 Percentage of Participants Interval 28.84 to 33.13
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Geriatric: >=65 Years	35.55 Percentage of Participants Interval 33.03 to 38.08
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Age: <30 Years	30.16 Percentage of Participants Interval 22.15 to 38.17
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Age: 40 to 49 Yeas	27.46 Percentage of Participants Interval 22.75 to 32.16
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Age: 50 to 64 Years	31.99 Percentage of Participants Interval 29.25 to 34.73
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Age: >=65 Years	35.55 Percentage of Participants Interval 33.03 to 38.08
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Sex: Male	32.55 Percentage of Participants Interval 30.53 to 34.56
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Sex: Female	33.79 Percentage of Participants Interval 30.98 to 36.6
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Duration of Disease: <3 Months	32.88 Percentage of Participants Interval 31.15 to 34.6
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Duration of Disease: >=3 Months and <6 Months	33.63 Percentage of Participants Interval 27.43 to 39.83
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Duration of Disease: >=6 Months	32.20 Percentage of Participants Interval 20.28 to 44.13
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Infection Site: cSSSI	28.79 Percentage of Participants Interval 25.95 to 31.63
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Infection Site: cIAI	34.87 Percentage of Participants Interval 32.76 to 36.99
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Infection Site: CAP	34.30 Percentage of Participants Interval 28.32 to 40.28
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Infection Site: cIAI + cSSSI	50.00 Percentage of Participants Interval 0.0 to 100.0
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Infection Site: cIAI + CAP	50.00 Percentage of Participants Interval 0.0 to 100.0
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Severity of Infection: Mild	26.83 Percentage of Participants Interval 21.7 to 31.96
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Severity of Infection: Moderate	27.27 Percentage of Participants Interval 25.35 to 29.19
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Severity of Infection: Severe	49.75 Percentage of Participants Interval 46.31 to 53.2
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics General Medical History: Yes	34.91 Percentage of Participants Interval 33.19 to 36.63
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics General Medical History: No	6.48 Percentage of Participants Interval 3.2 to 9.76
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics General Medical History (Present): Yes	35.03 Percentage of Participants Interval 33.29 to 36.76
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics General Medical History (Present): No	9.45 Percentage of Participants Interval 5.85 to 13.05
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics General Medical History (Past): Yes	37.10 Percentage of Participants Interval 34.14 to 40.05
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics General Medical History (Past): No	31.00 Percentage of Participants Interval 29.04 to 32.96
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Kidney Disorder: Yes	46.86 Percentage of Participants Interval 42.89 to 50.84
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Kidney Disorder: No	29.69 Percentage of Participants Interval 27.92 to 31.46
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Liver Disorder: Yes	39.82 Percentage of Participants Interval 36.65 to 43.0
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Liver Disorder: No	30.20 Percentage of Participants Interval 28.3 to 32.09
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Total Treatment Period of Tygacil: <7 Days	34.74 Percentage of Participants Interval 31.4 to 38.09
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Total Treatment Period of Tygacil: 7 to 14 Days	29.94 Percentage of Participants Interval 27.39 to 32.49
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Total Treatment Period of Tygacil: >14 Days	34.99 Percentage of Participants Interval 32.23 to 37.74
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Mean Daily Dose of Tygacil: <50 mg	100.00 Percentage of Participants Interval 100.0 to 100.0
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Mean Daily Dose of Tygacil: 50 to <100 mg	39.92 Percentage of Participants Interval 36.5 to 43.35
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Mean Daily Dose of Tygacil: 100 to <200 mg	30.57 Percentage of Participants Interval 28.72 to 32.42
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Mean Daily Dose of Tygacil: >=200 mg	60.00 Percentage of Participants Interval 17.06 to 100.0
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Past Medication and Therapy: Yes	33.48 Percentage of Participants Interval 31.77 to 35.19
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Past Medication and Therapy: No	27.02 Percentage of Participants Interval 21.49 to 32.54
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Concomitant Medications: Yes	33.77 Percentage of Participants Interval 32.09 to 35.45
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics Concomitant Medications: No	14.06 Percentage of Participants Interval 8.04 to 20.08

SECONDARY outcome

Timeframe: At the TOC or EOT assessment

Population: Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.

Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .

Outcome measures

Outcome measures
Measure	Tygacil n=2545 Participants Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment Prospectively Collected Data	59.68 Percentage of Participants Interval 55.63 to 63.73
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment Retrospectively Collected Data	74.97 Percentage of Participants Interval 73.07 to 76.88
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment Total	71.59 Percentage of Participants Interval 69.84 to 73.34

SECONDARY outcome

Timeframe: At the TOC or EOT assessment

Population: Effectiveness Analysis Set.

Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .

Outcome measures

Outcome measures
Measure	Tygacil n=2545 Participants Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site Infection Site: cSSSI	77.53 Percentage of Participants Interval 74.66 to 80.41
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site Infection Site: cIAI	71.52 Percentage of Participants Interval 69.28 to 73.76
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site Infection Site: CAP	45.35 Percentage of Participants Interval 37.91 to 52.79
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site Infection Site: cIAI + cSSSI	0.00 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site Infection Site: cIAI + CAP	50.00 Percentage of Participants Interval 0.0 to 100.0
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site Infection Site: Total	71.59 Percentage of Participants Interval 69.84 to 73.34

SECONDARY outcome

Timeframe: At the TOC or EOT assessment

Population: Effectiveness Analysis Set from the prospective study phase; n refers to the total nunber of participants who had evaluable data.

Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.

Outcome measures

Outcome measures
Measure	Tygacil n=563 Participants Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) Eradication (Documented or Presumed) (n=514)	46.69 Percentage of Participants
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) Persistence (Documented or Presumed) (n=514)	32.68 Percentage of Participants
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) Unevaluable (n=514)	20.62 Percentage of Participants

Adverse Events

Tygacil

Serious events: 419 serious events

Other events: 537 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tygacil n=3169 participants at risk Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
General disorders Exacerbation of disease	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mediastinitis	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Multiple organ failure	1.0% 33/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	0.16% 5/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Circulatory failure	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.22% 7/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Brain hypoxia	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Brain stem disorder	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Carboxyhaemoglobinaemia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsions	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Oedema cerebral	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Clostridial infection	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colitis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Colitis pseudomembranous	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric ulcer haemorrhagic	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal fistula	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal ischaemia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal perforation	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Melaena	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatitis	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Arrhythmia	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Bradycardia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac arrest	0.13% 4/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Fibrillation atrial	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Fibrillation ventricular	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sick sinus syndrome	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Bilirubinaemia	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic cirrhosis	0.16% 5/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic failure	0.35% 11/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatocellular damage	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatorenal syndrome	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Jaundice	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Serum glutamic oxaloacetic transaminase increased	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Serum glutamic pyruvate transaminase increased	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Acidosis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myositis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiomyopathy	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	0.13% 4/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial ischaemia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma small intestine	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia granulocytic	0.13% 4/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma malignant	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	1.4% 45/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Coagulation disorder	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.16% 5/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Haemorrhage not otherwise specified	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.25% 8/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.5% 47/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory distress syndrome	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory insufficiency	0.22% 7/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Stevens johnson syndrome	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Azotaemia	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.32% 10/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure chronic	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure chronic aggravated	0.25% 8/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal function abnormal	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Cerebral haemorrhage	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Cerebral infarction	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haematoma	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Thrombophlebitis deep	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leucopenia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukocytosis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Marrow depression	0.19% 6/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Pancytopenia	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Graft versus host disease	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Application site reaction	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Abscess	0.25% 8/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection aggravated	0.09% 3/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Peritonitis	0.19% 6/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pyelonephritis	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	4.4% 139/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound dehiscence	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Amputation	0.06% 2/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary carcinoma	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Surgical intervention	0.03% 1/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Tygacil n=3169 participants at risk Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Gastrointestinal disorders Diarrhoea	1.4% 45/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	5.4% 170/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	1.3% 42/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Serum glutamic oxaloacetic transaminase increased	2.3% 72/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Serum glutamic pyruvate transaminase increased	2.0% 62/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Phosphatase alkaline increased	1.3% 42/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 38/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Azotaemia	2.1% 66/3169 • From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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