Trial Outcomes & Findings for Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840) (NCT NCT00727298)
NCT ID: NCT00727298
Last Updated: 2015-12-01
Results Overview
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
Recruitment status
COMPLETED
Target enrollment
4485 participants
Primary outcome timeframe
Baseline to Month 24
Results posted on
2015-12-01
Participant Flow
Of 4485 total enrolled participants, 4465 received at least one infusion of infliximab and are included in the safety evaluation. 3228 of these participants were evaluable for all other study analyses.
Participant milestones
| Measure |
Infliximab
Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
|
|---|---|
|
Overall Study
STARTED
|
4485
|
|
Overall Study
COMPLETED
|
3228
|
|
Overall Study
NOT COMPLETED
|
1257
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)
Baseline characteristics by cohort
| Measure |
Infliximab
n=3228 Participants
Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
|
|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
1591 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
1554 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Specified
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 24Population: The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
Outcome measures
| Measure |
Infliximab 3-10 mg/kg
n=4465 Participants
Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
|
|---|---|
|
Number of Participants Experiencing at Least One Adverse Event
|
609 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102Population: The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.
Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.
Outcome measures
| Measure |
Infliximab 3-10 mg/kg
n=3228 Participants
Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
|
|---|---|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Not at all ill
|
0.7 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Borderline ill
|
1.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Mildly ill
|
4.9 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Moderately ill
|
17.6 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Markedly ill
|
51.2 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Severely ill
|
21.0 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Baseline - Extreme severe illness
|
2.8 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Not at all ill
|
5.1 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Borderline ill
|
10.5 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Mildly ill
|
23.6 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Moderately ill
|
27.7 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Markedly ill
|
24.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Severely ill
|
7.5 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 6 - Extreme severe illness
|
1.1 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Not at all ill
|
8.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Borderline ill
|
14.2 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Mildly ill
|
23.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Moderately ill
|
26.1 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Markedly ill
|
21.2 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Severely ill
|
5.9 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 14 - Extreme severe illness
|
0.8 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Not at all ill
|
10.6 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Borderline ill
|
14.8 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Mildly ill
|
22.7 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Moderately ill
|
25.5 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Markedly ill
|
19.5 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Severely ill
|
5.9 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 22 - Extreme severe illness
|
0.8 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Not at all ill
|
12.9 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Borderline ill
|
16.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Mildly ill
|
22.2 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Moderately ill
|
23.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Markedly ill
|
19.3 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Severely ill
|
4.8 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 54 - Extreme severe illness
|
1.0 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Not at all ill
|
17.2 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Borderline ill
|
16.5 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Mildly ill
|
21.1 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Moderately ill
|
22.2 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Markedly ill
|
17.1 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Severely ill
|
4.1 Percentage of Participants
|
|
Clinicians' Impression of Disease Severity From Baseline to Week 102
Week 102 - Extreme severe illness
|
1.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6, Week 14, Week 22, Week 54, Week 102Population: The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.
Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.
Outcome measures
| Measure |
Infliximab 3-10 mg/kg
n=3228 Participants
Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
|
|---|---|
|
Clinicians' Impression of Therapeutic Efficacy
Week 14: Unchanged
|
9.9 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 14: Not Assessable
|
1.5 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 14: Mild-to-Slight Improvement
|
15.1 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 6: Moderate-to-Clear Improvement
|
34.8 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 6: Unchanged
|
8.9 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 6: Not Assessable
|
1.4 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 6: Mild-to-Slight Improvement
|
17.4 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 6: Very Good-to-Full Improvement
|
37.3 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 6: Worsened
|
0.2 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 14: Moderate-to-Clear Improvement
|
30.1 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 14: Very Good-to Full Improvement
|
43.1 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 14: Worsened
|
0.3 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 22: Moderate-to-Clear Improvement
|
29.5 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 22: Unchanged
|
11.3 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 22: Not Assessable
|
1.9 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 22: Mild-to-Slight Improvement
|
13.0 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 22: Very Good-to-Full Improvement
|
43.9 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 22: Worsened
|
0.3 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 54: Moderate-to-Clear Improvement
|
27.0 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 54: Unchanged
|
15.1 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 54: Not Assessable
|
1.6 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 54: Mild-to-Slight Improvement
|
9.3 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 54: Very Good-to-Full Improvement
|
46.4 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 54: Worsened
|
0.5 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 102: Moderate-to-Clear Improvement
|
25.7 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 102: Unchanged
|
16.3 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 102: Not Assessable
|
1.7 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 102: Mild-to-Slight Improvement
|
5.6 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 102: Very Good-to-Full Improvement
|
50.0 Percentage of Participants
|
|
Clinicians' Impression of Therapeutic Efficacy
Week 102: Worsened
|
0.6 Percentage of Participants
|
Adverse Events
Infliximab
Serious events: 296 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab
n=4465 participants at risk
Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Cardiac disorders
Cadiovascular disorder
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Cardiac disorders
Tachycardia
|
0.22%
10/4465 • Number of events 10
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Eye disorders
Blindness transient
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Eye disorders
Eyelid Oedema
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Lip swelling
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Nausea
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Parathesia oral
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Retching
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Chest discomfort
|
0.13%
6/4465 • Number of events 9
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Chest pain
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Chills
|
0.11%
5/4465 • Number of events 5
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Condition aggravated
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Impaired healing
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Infusion related reaction
|
0.63%
28/4465 • Number of events 28
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Malaise
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Pyrexia
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
General disorders
Sense of oppression
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Immune system disorders
Anaphylactic reactions
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Immune system disorders
Anaphylactic shock
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Immune system disorders
Hypersensitivity
|
0.36%
16/4465 • Number of events 18
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Immune system disorders
Sarcoidosis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Anal abscess
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Arthritis bacterial
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Erysipelas
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Gastrointestinal infection
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Hepatitis B
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Herpes zoster
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Impetigo
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Infection
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Lobar pneumonia
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Pneumonia
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Pneumonia legionella
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Purulence
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Salmonellosis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Scrotal abscess
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Sepsis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Septic shock
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Infections and infestations
Urinary tract infection
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Antinuclear antibody increased
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Antinuclear antibody positive
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Blood pressure
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Blood pressure decreased
|
0.11%
5/4465 • Number of events 5
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Blood pressure increased
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Blood pressure orthostatic
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
DNA antibody positive
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
Systemic lupus erythematosus disease activity index abnormal
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Investigations
White blood cell count increased
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular fasciitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Dizziness
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Headache
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Neuritis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Parathesia
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Presyncope
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Nervous system disorders
Syncope
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.11%
5/4465 • Number of events 5
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Psychiatric disorders
Depression
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Psychiatric disorders
Panic attack
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.09%
4/4465 • Number of events 4
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
31/4465 • Number of events 36
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.02%
1/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.02%
1/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.09%
4/4465 • Number of events 4
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Pruritis generalised
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Uticaria
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Abscess drainage
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Appendicectomy
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Arthrodesis
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Bunion operation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Bursa removal
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Cataract operation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Elbow operation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Foot operation
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Hip surgery
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Hospitalisation
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Limb operation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Polypectomy
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Proctocolectomy
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Rheumatoid nodule removal
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Shoulder operation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Surgery
|
0.07%
3/4465 • Number of events 3
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Synovectomy
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Surgical and medical procedures
Thyroid operation
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Vascular disorders
Flushing
|
0.22%
10/4465 • Number of events 10
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Vascular disorders
Hypertension
|
0.13%
6/4465 • Number of events 6
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Vascular disorders
Hypertensive crisis
|
0.04%
2/4465 • Number of events 2
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
|
Vascular disorders
Hypotension
|
0.02%
1/4465 • Number of events 1
The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place