Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064) (NCT NCT01945281)
NCT ID: NCT01945281
Last Updated: 2019-11-25
Results Overview
Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Up to 104 days
Results posted on
2019-11-25
Participant Flow
Participants less than 3 months of age with invasive candidiasis were enrolled in this study.
Participant milestones
| Measure |
Caspofungin
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
17
|
|
Overall Study
Treated
|
33
|
16
|
|
Overall Study
COMPLETED
|
28
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Caspofungin
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Technical Problems
|
1
|
0
|
Baseline Characteristics
Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
Baseline characteristics by cohort
| Measure |
Caspofungin
n=34 Participants
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
n=17 Participants
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 Days
STANDARD_DEVIATION 20.9 • n=34 Participants
|
32.8 Days
STANDARD_DEVIATION 23.3 • n=17 Participants
|
31.7 Days
STANDARD_DEVIATION 21.5 • n=51 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=34 Participants
|
10 Participants
n=17 Participants
|
24 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=34 Participants
|
7 Participants
n=17 Participants
|
27 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=34 Participants
|
7 Participants
n=17 Participants
|
19 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=34 Participants
|
9 Participants
n=17 Participants
|
28 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=34 Participants
|
1 Participants
n=17 Participants
|
4 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=34 Participants
|
1 Participants
n=17 Participants
|
4 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=34 Participants
|
6 Participants
n=17 Participants
|
19 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=34 Participants
|
8 Participants
n=17 Participants
|
21 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=34 Participants
|
2 Participants
n=17 Participants
|
7 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=51 Participants
|
|
Weight
|
1982.1 Grams
STANDARD_DEVIATION 980.6 • n=31 Participants • Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
|
2160.9 Grams
STANDARD_DEVIATION 1513.8 • n=16 Participants • Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
|
2042.9 Grams
STANDARD_DEVIATION 1175.5 • n=47 Participants • Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
|
PRIMARY outcome
Timeframe: Up to 104 daysPopulation: Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.
Outcome measures
| Measure |
Caspofungin
n=31 Participants
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
n=16 Participants
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period
|
71.0 Percentage of Participants
Interval 52.0 to 85.8
|
68.8 Percentage of Participants
Interval 41.3 to 89.0
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.
Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.
Outcome measures
| Measure |
Caspofungin
n=31 Participants
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
n=16 Participants
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Percentage of Participants With Fungal-free Survival Through the End of Study Treatment
|
71.0 Percentage of Participants
Interval 52.0 to 85.8
|
75.0 Percentage of Participants
Interval 47.6 to 92.7
|
SECONDARY outcome
Timeframe: 8 weeks after end of study therapy (up to 146 days)Population: All participants as treated
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, 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 SPONSOR's product, is also an AE.
Outcome measures
| Measure |
Caspofungin
n=33 Participants
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
n=16 Participants
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
28 Participants
|
16 Participants
|
Adverse Events
Caspofungin
Serious events: 7 serious events
Other events: 23 other events
Deaths: 2 deaths
Amphotericin B Deoxycholate
Serious events: 9 serious events
Other events: 15 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Caspofungin
n=33 participants at risk
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
n=16 participants at risk
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Necrotising colitis
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Endocarditis
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Escherichia sepsis
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Fungal infection
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Pneumonia
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Septic shock
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Vascular disorders
Superior vena cava syndrome
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
Other adverse events
| Measure |
Caspofungin
n=33 participants at risk
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
Amphotericin B Deoxycholate
n=16 participants at risk
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.3%
10/33 • Number of events 16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
50.0%
8/16 • Number of events 12 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Blood and lymphatic system disorders
Leukostasis syndrome
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 3 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Cardiac disorders
Tachycardia
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Eye disorders
Eye discharge
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Abdominal distension
|
3.0%
1/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
3.0%
1/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
3/33 • Number of events 4 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
General disorders
Hypothermia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
General disorders
Pyrexia
|
18.2%
6/33 • Number of events 10 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
18.8%
3/16 • Number of events 6 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Hepatobiliary disorders
Cholestasis
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Abscess limb
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Postoperative wound infection
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Sepsis
|
9.1%
3/33 • Number of events 5 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
31.2%
5/16 • Number of events 6 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Septic shock
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Infections and infestations
Staphylococcal sepsis
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
18.8%
3/16 • Number of events 3 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 3 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Blood potassium increased
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
0.00%
0/16 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.1%
2/33 • Number of events 3 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
12.5%
2/16 • Number of events 5 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
2/33 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.1%
3/33 • Number of events 3 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Nervous system disorders
Seizure
|
3.0%
1/33 • Number of events 5 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
3.0%
1/33 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 2 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/33 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
6.2%
1/16 • Number of events 1 • 8 weeks after end of study therapy (up to 146 days)
All participants as treated
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER