Trial Outcomes & Findings for PegIntron Injection Surveillance Plan (Study P04123) (NCT NCT00723931)
NCT ID: NCT00723931
Last Updated: 2015-11-04
Results Overview
Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.
Recruitment status
COMPLETED
Target enrollment
1267 participants
Primary outcome timeframe
24 weeks after administration of PegIntron Injection
Results posted on
2015-11-04
Participant Flow
Participant milestones
| Measure |
Pegintron/Pegintron Redipen Injection
Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
|
|---|---|
|
Overall Study
STARTED
|
1267
|
|
Overall Study
COMPLETED
|
1267
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PegIntron Injection Surveillance Plan (Study P04123)
Baseline characteristics by cohort
| Measure |
Pegintron/Pegintron Redipen Injection
n=1267 Participants
Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
|
|---|---|
|
Age, Customized
Between 16 and 80 years
|
1267 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
585 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
682 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after administration of PegIntron InjectionSerious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.
Outcome measures
| Measure |
Pegintron/Pegintron Redipen Injection
n=1267 Participants
Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
|
|---|---|
|
Number of Participants That Reported a Serious Adverse Event
|
15 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after administration of PegIntron Injection.Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.
Outcome measures
| Measure |
Pegintron/Pegintron Redipen Injection
n=1267 Participants
Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
|
|---|---|
|
Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold
|
820 Participants
|
Adverse Events
Pegintron/Pegintron Redipen Injection
Serious events: 15 serious events
Other events: 820 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegintron/Pegintron Redipen Injection
n=1267 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
1/1267 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
0.08%
1/1267 • Number of events 1
|
|
Cardiac disorders
Cardiac Failure
|
0.08%
1/1267 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.08%
1/1267 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.08%
1/1267 • Number of events 1
|
|
General disorders
Chest Pain
|
0.08%
1/1267 • Number of events 1
|
|
Infections and infestations
Bronchiectasis
|
0.08%
1/1267 • Number of events 1
|
|
Infections and infestations
Empyema
|
0.08%
1/1267 • Number of events 1
|
|
Infections and infestations
Herpes Zoster
|
0.08%
1/1267 • Number of events 1
|
|
Infections and infestations
Meningitis Cryptococcal
|
0.08%
1/1267 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1267 • Number of events 1
|
|
Investigations
Blood Amylase Increased
|
0.08%
1/1267 • Number of events 1
|
|
Investigations
Lipase Increased
|
0.08%
1/1267 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.08%
1/1267 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.08%
1/1267 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant Recurrent
|
0.08%
1/1267 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.08%
1/1267 • Number of events 1
|
|
Psychiatric disorders
Homicidal Ideation
|
0.08%
1/1267 • Number of events 1
|
|
Psychiatric disorders
Suicide Attempt
|
0.08%
1/1267 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.08%
1/1267 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.16%
2/1267 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.08%
1/1267 • Number of events 1
|
Other adverse events
| Measure |
Pegintron/Pegintron Redipen Injection
n=1267 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.7%
237/1267 • Number of events 243
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.4%
144/1267 • Number of events 152
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.4%
81/1267 • Number of events 84
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
102/1267 • Number of events 112
|
|
Gastrointestinal disorders
Nausea
|
5.4%
69/1267 • Number of events 76
|
|
General disorders
Asthenia
|
6.3%
80/1267 • Number of events 87
|
|
General disorders
Fatigue
|
5.5%
70/1267 • Number of events 76
|
|
General disorders
Pyrexia
|
5.6%
71/1267 • Number of events 86
|
|
Investigations
White Blood Cell Count Decreased
|
7.7%
97/1267 • Number of events 107
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.8%
124/1267 • Number of events 137
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
227/1267 • Number of events 275
|
|
Nervous system disorders
Headache
|
17.8%
226/1267 • Number of events 288
|
|
Psychiatric disorders
Insomnia
|
6.5%
82/1267 • Number of events 87
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
82/1267 • Number of events 84
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.4%
182/1267 • Number of events 198
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
70/1267 • Number of events 77
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp and Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place