Trial Outcomes & Findings for PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) (NCT NCT00536263)
NCT ID: NCT00536263
Last Updated: 2017-04-07
Results Overview
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
671 participants
Primary outcome timeframe
24 weeks after end of treatment (EOT)
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Overall Study
STARTED
|
225
|
221
|
225
|
|
Overall Study
COMPLETED
|
214
|
207
|
204
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
21
|
Reasons for withdrawal
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
4
|
|
Overall Study
Subject withdrew - not treatment related
|
2
|
0
|
5
|
|
Overall Study
Subject withdrew - treatment related
|
0
|
3
|
2
|
|
Overall Study
Noncompliance with protocol
|
0
|
0
|
1
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
2
|
2
|
Baseline Characteristics
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
Baseline characteristics by cohort
| Measure |
PEG 1.0 mcg/kg QW * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up; treated participants
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up; treated participants
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up; treated participants.
|
Total
n=670 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.2 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
27.5 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
28.4 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
28.0 Years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
504 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after end of treatment (EOT)Population: Treated participants
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
|
39 Participants
|
40 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Up to Treatment Week 48Population: Treated participants
HBeAg Loss was tested by assay of Abbott MEIA
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With HBeAg Loss
|
31 Participants
|
28 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
HBe Seroconversion
EOT
|
31 Participants
|
27 Participants
|
40 Participants
|
|
HBe Seroconversion
24 weeks after EOT
|
38 Participants
|
36 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
EOT
|
46 Participants
|
61 Participants
|
76 Participants
|
|
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
24 weeks after EOT
|
44 Participants
|
47 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With HBV-DNA < 200 IU/mL
24 weeks after EOT
|
12 Participants
|
12 Participants
|
22 Participants
|
|
Number of Participants With HBV-DNA < 200 IU/mL
EOT
|
10 Participants
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
Undetectable HBV-DNA was defined as having a level \<6 IU/mL by polymerase chain reaction (PCR).
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With HBV-DNA Undetectable
EOT
|
4 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With HBV-DNA Undetectable
24 weeks after EOT
|
4 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
Biochemical response was defined as alanine aminotransferase (ALT) normalization.
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With Biochemical Response
EOT
|
75 Participants
|
86 Participants
|
103 Participants
|
|
Number of Participants With Biochemical Response
24 weeks after EOT
|
63 Participants
|
80 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
Combined response was defined as HBV DNA \<20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Number of Participants With Combined Response
EOT
|
11 Participants
|
11 Participants
|
23 Participants
|
|
Number of Participants With Combined Response
24 weeks after EOT
|
18 Participants
|
23 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
HBsAg Loss was tested by assay of Abbott MEIA
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Hepatitis B Surface Antigen (HBsAg) Loss
EOT
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Hepatitis B Surface Antigen (HBsAg) Loss
24 weeks after EOT
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: End of treatment (EOT) and 24 weeks after EOTPopulation: Treated participants
HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=225 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=221 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=224 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Hepatitis B Surface Antigen (HBs) Seroconversion
EOT
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Hepatitis B Surface Antigen (HBs) Seroconversion
24 weeks after EOT
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks after end of treatmentPopulation: Treated participants from designated sites
Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked \[involvement of \>2/3 of lobules or nodules\]). Score III (portal inflammation): 0 (none) to 4 (Marked \[dense packing of inflammatory cells in \>2/3 of portal tracts\]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis).
Outcome measures
| Measure |
PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks
n=64 Participants
PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 24 Weeks
n=64 Participants
PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up
|
PEG 1.5 mcg/kg QW * 48 Weeks
n=46 Participants
PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up
|
|---|---|---|---|
|
Change From Baseline in Liver Biopsy Score
Baseline
|
8.0 Units on a scale
Standard Deviation 3.06
|
8.4 Units on a scale
Standard Deviation 2.92
|
8.2 Units on a scale
Standard Deviation 3.33
|
|
Change From Baseline in Liver Biopsy Score
Change from Baseline
|
-1.1 Units on a scale
Standard Deviation 3.57
|
-1.7 Units on a scale
Standard Deviation 3.66
|
-1.6 Units on a scale
Standard Deviation 3.96
|
Adverse Events
PEG 1.0 mcg/kg QW x24 Weeks
Serious events: 10 serious events
Other events: 173 other events
Deaths: 0 deaths
PEG 1.5 mcg/kg QW x24 Weeks
Serious events: 11 serious events
Other events: 169 other events
Deaths: 0 deaths
PEG 1.5 mcg/kg QW x48 Weeks
Serious events: 15 serious events
Other events: 182 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG 1.0 mcg/kg QW x24 Weeks
n=225 participants at risk
|
PEG 1.5 mcg/kg QW x24 Weeks
n=221 participants at risk
|
PEG 1.5 mcg/kg QW x48 Weeks
n=224 participants at risk
|
|---|---|---|---|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Eye disorders
OCULAR ICTERUS
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
General disorders
FATIGUE
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
1.4%
3/221 • Number of events 4
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Hepatobiliary disorders
HEPATITIS
|
1.8%
4/225 • Number of events 4
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Infections and infestations
HEPATITIS B
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.90%
2/221 • Number of events 2
Population was all treated participants.
|
1.3%
3/224 • Number of events 3
Population was all treated participants.
|
|
Infections and infestations
PARATYPHOID FEVER
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
1.8%
4/221 • Number of events 4
Population was all treated participants.
|
0.89%
2/224 • Number of events 2
Population was all treated participants.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/225
Population was all treated participants.
|
1.8%
4/221 • Number of events 4
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Investigations
THYROID FUNCTION TEST ABNORMAL
|
0.00%
0/225
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.45%
1/224 • Number of events 1
Population was all treated participants.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
1.4%
3/221 • Number of events 4
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Nervous system disorders
SPEECH DISORDER
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Psychiatric disorders
AGGRESSION
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/225
Population was all treated participants.
|
0.90%
2/221 • Number of events 2
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Psychiatric disorders
HALLUCINATION
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Psychiatric disorders
INSOMNIA
|
0.44%
1/225 • Number of events 1
Population was all treated participants.
|
0.00%
0/221
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
|
Psychiatric disorders
MANIA
|
0.00%
0/225
Population was all treated participants.
|
0.45%
1/221 • Number of events 1
Population was all treated participants.
|
0.00%
0/224
Population was all treated participants.
|
Other adverse events
| Measure |
PEG 1.0 mcg/kg QW x24 Weeks
n=225 participants at risk
|
PEG 1.5 mcg/kg QW x24 Weeks
n=221 participants at risk
|
PEG 1.5 mcg/kg QW x48 Weeks
n=224 participants at risk
|
|---|---|---|---|
|
General disorders
ASTHENIA
|
5.3%
12/225 • Number of events 15
Population was all treated participants.
|
11.3%
25/221 • Number of events 40
Population was all treated participants.
|
6.7%
15/224 • Number of events 21
Population was all treated participants.
|
|
General disorders
FATIGUE
|
15.6%
35/225 • Number of events 106
Population was all treated participants.
|
13.1%
29/221 • Number of events 119
Population was all treated participants.
|
18.8%
42/224 • Number of events 153
Population was all treated participants.
|
|
General disorders
PYREXIA
|
69.3%
156/225 • Number of events 253
Population was all treated participants.
|
71.5%
158/221 • Number of events 316
Population was all treated participants.
|
75.0%
168/224 • Number of events 444
Population was all treated participants.
|
|
Investigations
WEIGHT DECREASED
|
2.2%
5/225 • Number of events 5
Population was all treated participants.
|
1.4%
3/221 • Number of events 3
Population was all treated participants.
|
7.1%
16/224 • Number of events 19
Population was all treated participants.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
3.6%
8/225 • Number of events 9
Population was all treated participants.
|
7.2%
16/221 • Number of events 22
Population was all treated participants.
|
7.6%
17/224 • Number of events 38
Population was all treated participants.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.0%
18/225 • Number of events 38
Population was all treated participants.
|
6.3%
14/221 • Number of events 32
Population was all treated participants.
|
5.4%
12/224 • Number of events 53
Population was all treated participants.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
24.0%
54/225 • Number of events 108
Population was all treated participants.
|
31.7%
70/221 • Number of events 137
Population was all treated participants.
|
34.4%
77/224 • Number of events 206
Population was all treated participants.
|
|
Nervous system disorders
DIZZINESS
|
8.0%
18/225 • Number of events 37
Population was all treated participants.
|
9.5%
21/221 • Number of events 44
Population was all treated participants.
|
9.8%
22/224 • Number of events 42
Population was all treated participants.
|
|
Nervous system disorders
HEADACHE
|
20.9%
47/225 • Number of events 116
Population was all treated participants.
|
29.9%
66/221 • Number of events 187
Population was all treated participants.
|
26.3%
59/224 • Number of events 178
Population was all treated participants.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
6.7%
15/225 • Number of events 16
Population was all treated participants.
|
8.6%
19/221 • Number of events 19
Population was all treated participants.
|
12.5%
28/224 • Number of events 28
Population was all treated participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) agrees not to publish/present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication/presentation to permit the sponsor to review copies of abstracts/manuscripts which report any study results. The sponsor shall have the right to review and comment. If the parties disagree the PI agrees to meet with the sponsor to discuss and resolve.
- Publication restrictions are in place
Restriction type: OTHER