Trial Outcomes & Findings for Post-Marketing Study Of The Safety Of Tygacil (Tigecycline) (NCT NCT00683332)

NCT ID: NCT00683332

Last Updated: 2011-07-08

Results Overview

Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"

• Recruitment status: COMPLETED
• Target enrollment: 621 participants
• Primary outcome timeframe: 30 days post injection up to 3 years
• Results posted on: 2011-07-08

Participant Flow

Participant milestones

Measure	Tygacil 50 mg Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Overall Study STARTED	621
Overall Study COMPLETED	621
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

Baseline characteristics by cohort

Measure	Tygacil 50 mg n=621 Participants Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Age Continuous	55.7 Years STANDARD_DEVIATION 17.4 • n=5 Participants
Sex: Female, Male Female	254 Participants n=5 Participants
Sex: Female, Male Male	367 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post injection up to 3 years

Population: Safety Population: All participants who received at least 1 dose of tygacil

Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"

Outcome measures

Measure	Tygacil 50 mg n=621 Participants Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Number of Participants With Spontaneous Adverse Events	17 Participants

Adverse Events

Tygacil 50 mg

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tygacil 50 mg n=621 participants at risk Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Cardiac disorders Cardiopulmonary Arrest	0.64% 4/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious 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 Haematuria	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Tygacil 50 mg n=621 participants at risk Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Blood and lymphatic system disorders Eosinophilia	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.81% 5/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine Aminotransferase Increased	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious 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 Arthralgia	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.16% 1/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious 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 Phlebitis	0.32% 2/621 • 30 days post injection up to 3 years The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious 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: ClinicalTrials.gov_Inquiries@pfizer.com

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