Trial Outcomes & Findings for Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641) (NCT NCT00726609)
NCT ID: NCT00726609
Last Updated: 2015-03-05
Results Overview
The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.
Recruitment status
COMPLETED
Target enrollment
214 participants
Primary outcome timeframe
Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.
Results posted on
2015-03-05
Participant Flow
Participant milestones
| Measure |
Posaconazole (Assigned by Physician in Normal Practice)
* Treatment of invasive fungal infection.
* Prophylaxis of invasive fungal infection.
|
|---|---|
|
Overall Study
STARTED
|
214
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
98
|
Reasons for withdrawal
| Measure |
Posaconazole (Assigned by Physician in Normal Practice)
* Treatment of invasive fungal infection.
* Prophylaxis of invasive fungal infection.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
25
|
|
Overall Study
Other
|
3
|
|
Overall Study
Missing
|
42
|
Baseline Characteristics
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Baseline characteristics by cohort
| Measure |
Posaconazole (Assigned by Physician in Normal Practice)
n=214 Participants
* Treatment of invasive fungal infection.
* Prophylaxis of invasive fungal infection.
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
214 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.
Outcome measures
| Measure |
Posaconazole (Assigned by Physician in Normal Practice)
n=214 Participants
* Treatment of invasive fungal infection.
* Prophylaxis of invasive fungal infection.
|
|---|---|
|
Number of Participants Reporting Adverse Drug Reactions.
All
|
52 Participants
|
|
Number of Participants Reporting Adverse Drug Reactions.
Mild
|
30 Participants
|
|
Number of Participants Reporting Adverse Drug Reactions.
Moderate
|
21 Participants
|
|
Number of Participants Reporting Adverse Drug Reactions.
Severe
|
1 Participants
|
Adverse Events
Posaconazole (Assigned by Physician in Normal Practice)
Serious events: 33 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Posaconazole (Assigned by Physician in Normal Practice)
n=214 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.47%
1/214 • Number of events 1
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.47%
1/214 • Number of events 1
|
|
Congenital, familial and genetic disorders
CYSTIC LYMPHANGIOMA
|
0.47%
1/214 • Number of events 1
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.93%
2/214 • Number of events 2
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.47%
1/214 • Number of events 1
|
|
General disorders
CHEST PAIN
|
0.47%
1/214 • Number of events 1
|
|
General disorders
DEATH
|
0.93%
2/214 • Number of events 2
|
|
General disorders
DISEASE PROGRESSION
|
0.93%
2/214 • Number of events 2
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.47%
1/214 • Number of events 1
|
|
General disorders
INJECTION SITE THROMBOSIS
|
0.47%
1/214 • Number of events 1
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.93%
2/214 • Number of events 3
|
|
General disorders
PYREXIA
|
0.47%
1/214 • Number of events 2
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.47%
1/214 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.93%
2/214 • Number of events 2
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.47%
1/214 • Number of events 1
|
|
Immune system disorders
ACUTE GRAFT VERSUS HOST DISEASE
|
0.47%
1/214 • Number of events 1
|
|
Immune system disorders
ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE
|
0.47%
1/214 • Number of events 1
|
|
Immune system disorders
ACUTE GRAFT VERSUS HOST DISEASE IN LIVER
|
0.47%
1/214 • Number of events 1
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
ABSCESS LIMB
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
ABSCESS SWEAT GLAND
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
1.9%
4/214 • Number of events 4
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.93%
2/214 • Number of events 3
|
|
Infections and infestations
INFECTION
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
OTITIS MEDIA BACTERIAL
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
SEPSIS
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
SEPTIC SHOCK
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
SKIN INFECTION
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
2.8%
6/214 • Number of events 10
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
UROSEPSIS
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.47%
1/214 • Number of events 1
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.47%
1/214 • Number of events 1
|
|
Investigations
BLOOD CULTURE POSITIVE
|
0.47%
1/214 • Number of events 4
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.93%
2/214 • Number of events 2
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.47%
1/214 • Number of events 1
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.93%
2/214 • Number of events 2
|
|
Investigations
RENAL FUNCTION TEST ABNORMAL
|
0.93%
2/214 • Number of events 2
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FACET JOINT SYNDROME
|
0.47%
1/214 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.47%
1/214 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATIC ADENOMA
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
CRITICAL ILLNESS POLYNEUROPATHY
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
ENCEPHALITIS
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
TOXIC NEUROPATHY
|
0.47%
1/214 • Number of events 1
|
|
Psychiatric disorders
TRANSIENT PSYCHOSIS
|
0.47%
1/214 • Number of events 1
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.47%
1/214 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.47%
1/214 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
1.4%
3/214 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.47%
1/214 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
SUBCLAVIAN VEIN THROMBOSIS
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
THROMBOSIS
|
0.47%
1/214 • Number of events 1
|
Other adverse events
| Measure |
Posaconazole (Assigned by Physician in Normal Practice)
n=214 participants at risk
|
|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
8.9%
19/214 • Number of events 19
|
|
Gastrointestinal disorders
NAUSEA
|
5.6%
12/214 • Number of events 18
|
|
General disorders
PYREXIA
|
12.6%
27/214 • Number of events 34
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
5.1%
11/214 • Number of events 11
|
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