Trial Outcomes & Findings for B0151005 Open-Label Extension Study (NCT NCT01345318)
NCT ID: NCT01345318
Last Updated: 2024-01-12
Results Overview
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Baseline up to Week 48
Results posted on
2024-01-12
Participant Flow
Participant milestones
| Measure |
PF-04236921
All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Overall Study
STARTED
|
191
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
PF-04236921
All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Lack of Efficacy
|
17
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
41
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
B0151005 Open-Label Extension Study
Baseline characteristics by cohort
| Measure |
PF-04236921
n=191 Participants
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
FEMALE
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
MALE
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 48Population: The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Outcome measures
| Measure |
PF-04236921
n=191 Participants
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Participants with AEs
|
171 participants
|
|
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Participants with SAEs
|
58 participants
|
|
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Participants discontinued due to AEs
|
54 participants
|
PRIMARY outcome
Timeframe: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.Population: The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.
Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (\>=) 4.32. Any positive ADA sample was further tested for NAbs.
Outcome measures
| Measure |
PF-04236921
n=191 Participants
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
ADA positive
|
0.52 percentage of participants
|
|
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
NAbs positive
|
0.52 percentage of participants
|
Adverse Events
PF-04236921
Serious events: 79 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04236921
n=191 participants at risk
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Ulcerative keratitis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Anal fistula
|
2.1%
4/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
21.5%
41/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.6%
3/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abdominal abscess
|
2.1%
4/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Anal abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bartholin's abscess
|
0.93%
1/108
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Groin abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infectious colitis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Latent tuberculosis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Mesenteric abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Perirectal abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Peritonitis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Peritonsillar abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rectal abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Septic shock
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tuberculosis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral infection
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.93%
1/108
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
2/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.52%
1/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
PF-04236921
n=191 participants at risk
All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.9%
15/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.4%
39/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
23.6%
45/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
20/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
11.0%
21/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
22/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
7.3%
14/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
6.3%
12/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
5.8%
11/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
31/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
11/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
8.4%
16/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
23/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
12/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
12.0%
23/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
5.2%
10/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.8%
11/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
13/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.3%
14/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
18/191
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER