Trial Outcomes & Findings for SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002) (NCT NCT03552549)

Last Updated: 2019-07-24

Results Overview

Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

126 participants

Primary outcome timeframe

From time of randomization to time of progression or death (up to approximately 26 months)

Results posted on

2019-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	PEG-Intron Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery	INTRON A Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery
Overall Study STARTED	63	63
Overall Study Treated	62	62
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	53	52

Reasons for withdrawal

Reasons for withdrawal
Measure	PEG-Intron Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery	INTRON A Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery
Overall Study Disease progression	25	17
Overall Study Adverse event in first 12 months	12	8
Overall Study Withdrawal by Subject	7	7
Overall Study Unknown (no reason provided)	4	2
Overall Study Not in participant's best interest	2	1
Overall Study Did not complete study treatment	2	3
Overall Study Did not meet eligibility criteria	1	0
Overall Study Administrative	0	14

Baseline Characteristics

Age is unknown for 1 participant in each treatment group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG-Intron n=63 Participants Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery	INTRON A n=63 Participants Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery	Total n=126 Participants Total of all reporting groups
Age, Continuous	48.1 Years STANDARD_DEVIATION 13.6 • n=62 Participants • Age is unknown for 1 participant in each treatment group.	49.2 Years STANDARD_DEVIATION 12.2 • n=62 Participants • Age is unknown for 1 participant in each treatment group.	48.6 Years STANDARD_DEVIATION 12.9 • n=124 Participants • Age is unknown for 1 participant in each treatment group.
Sex: Female, Male Female	24 Participants n=63 Participants	22 Participants n=63 Participants	46 Participants n=126 Participants
Sex: Female, Male Male	39 Participants n=63 Participants	41 Participants n=63 Participants	80 Participants n=126 Participants

PRIMARY outcome

Timeframe: From time of randomization to time of progression or death (up to approximately 26 months)

Population: All randomized participants. Due to the early termination of this study, confirmation of PFS by Independent Central Review was not collected and; therefore, PFS could not be analyzed as planned per protocol.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of randomization to time of death (up to approximately 26 months)

Population: All treated participants.

Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.

Outcome measures

Outcome measures
Measure	PEG-Intron n=62 Participants Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery	INTRON A n=62 Participants Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery
Overall Survival	NA Months Interval 25.63 to NA=Median OS could not be calculated due to an insufficient number of deaths on study (i.e. median OS was not reached). NA=Upper limit OS could not be calculated due to an insufficient number of deaths on study (i.e. upper limit OS was not reached).	23.72 Months Interval 20.67 to NA=Upper limit OS could not be calculated due to an insufficient number of deaths on study (i.e. upper limit OS was not reached).

Adverse Events

PEG-Intron

Serious events: 24 serious events

Other events: 61 other events

Deaths: 11 deaths

INTRON A

Serious events: 19 serious events

Other events: 60 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

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 Principal Investigator agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of the Sponsor. The Principal Investigator further agrees to provide to the Sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the Protocol study.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	PEG-Intron n=63 participants at risk Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery	INTRON A n=63 participants at risk Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery
Blood and lymphatic system disorders LYMPHADENOPATHY	4.8% 3/63 • Number of events 3 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Blood and lymphatic system disorders NEUTROPENIA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Cardiac disorders TACHYARRHYTHMIA	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Ear and labyrinth disorders VERTIGO	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Eye disorders EYELID PTOSIS	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Eye disorders VISION BLURRED	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders ABDOMINAL PAIN	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders DIARRHOEA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders NAUSEA	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders VOMITING	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders ASTHENIA	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders INJECTION SITE ERYTHEMA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders INJECTION SITE NECROSIS	3.2% 2/63 • Number of events 3 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders MUCOSAL INFLAMMATION	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders PYREXIA	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations BRONCHITIS	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations CELLULITIS	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations GROIN INFECTION	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations INCISION SITE CELLULITIS	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations LOBAR PNEUMONIA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations PNEUMONIA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations POSTOPERATIVE WOUND INFECTION	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations URINARY TRACT INFECTION	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations WOUND ABSCESS	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations WOUND INFECTION	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Injury, poisoning and procedural complications INJURY	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Injury, poisoning and procedural complications PROCEDURAL PAIN	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Injury, poisoning and procedural complications SEROMA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations ALANINE AMINOTRANSFERASE INCREASED	3.2% 2/63 • Number of events 3 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	1.6% 1/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations GRANULOCYTE COUNT DECREASED	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations HEPATIC ENZYME INCREASED	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 5 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations TRANSAMINASES INCREASED	1.6% 1/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations WHITE BLOOD CELL COUNT DECREASED	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Metabolism and nutrition disorders ANOREXIA	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.

Other adverse events
Measure	PEG-Intron n=63 participants at risk Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery	INTRON A n=63 participants at risk Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units \[MIU\]/m\^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m\^2 three times per week) for up to 12 months post-surgery
Blood and lymphatic system disorders LEUKOPENIA	11.1% 7/63 • Number of events 20 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Blood and lymphatic system disorders NEUTROPENIA	6.3% 4/63 • Number of events 5 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Blood and lymphatic system disorders THROMBOCYTOPENIA	6.3% 4/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 5 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Ear and labyrinth disorders VERTIGO	11.1% 7/63 • Number of events 24 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 22 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Eye disorders EYE PAIN	7.9% 5/63 • Number of events 13 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	7.9% 5/63 • Number of events 7 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders ABDOMINAL PAIN	19.0% 12/63 • Number of events 18 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	4.8% 3/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	9.5% 6/63 • Number of events 9 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	11.1% 7/63 • Number of events 8 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders CONSTIPATION	7.9% 5/63 • Number of events 10 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	14.3% 9/63 • Number of events 10 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders DIARRHOEA	33.3% 21/63 • Number of events 65 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	23.8% 15/63 • Number of events 26 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders DRY MOUTH	15.9% 10/63 • Number of events 36 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	23.8% 15/63 • Number of events 23 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders DYSPEPSIA	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders NAUSEA	46.0% 29/63 • Number of events 89 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	42.9% 27/63 • Number of events 57 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Gastrointestinal disorders VOMITING	31.7% 20/63 • Number of events 79 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	20.6% 13/63 • Number of events 21 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders ASTHENIA	34.9% 22/63 • Number of events 47 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	23.8% 15/63 • Number of events 31 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders CHILLS	38.1% 24/63 • Number of events 56 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	50.8% 32/63 • Number of events 76 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders FATIGUE	41.3% 26/63 • Number of events 186 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	44.4% 28/63 • Number of events 54 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders INFLUENZA LIKE ILLNESS	22.2% 14/63 • Number of events 53 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	17.5% 11/63 • Number of events 39 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders INJECTION SITE ERYTHEMA	15.9% 10/63 • Number of events 40 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders INJECTION SITE PAIN	7.9% 5/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 3 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders INJECTION SITE REACTION	7.9% 5/63 • Number of events 7 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders MALAISE	9.5% 6/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 8 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders OEDEMA PERIPHERAL	6.3% 4/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	7.9% 5/63 • Number of events 5 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders PAIN	17.5% 11/63 • Number of events 77 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	12.7% 8/63 • Number of events 11 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
General disorders PYREXIA	57.1% 36/63 • Number of events 211 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	47.6% 30/63 • Number of events 65 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations BRONCHITIS	6.3% 4/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations INFLUENZA	6.3% 4/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	4.8% 3/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Infections and infestations NASOPHARYNGITIS	7.9% 5/63 • Number of events 11 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations BODY TEMPERATURE INCREASED	20.6% 13/63 • Number of events 15 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	15.9% 10/63 • Number of events 11 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations HEPATIC ENZYME INCREASED	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 4 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations TRANSAMINASES INCREASED	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Investigations WEIGHT DECREASED	11.1% 7/63 • Number of events 9 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	7.9% 5/63 • Number of events 5 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Metabolism and nutrition disorders ANOREXIA	36.5% 23/63 • Number of events 51 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	23.8% 15/63 • Number of events 20 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Metabolism and nutrition disorders DECREASED APPETITE	9.5% 6/63 • Number of events 7 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	11.1% 7/63 • Number of events 10 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders ARTHRALGIA	23.8% 15/63 • Number of events 52 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	6.3% 4/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders BACK PAIN	31.7% 20/63 • Number of events 81 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	23.8% 15/63 • Number of events 22 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	1.6% 1/63 • Number of events 1 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	7.9% 5/63 • Number of events 11 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	6.3% 4/63 • Number of events 8 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	0.00% 0/63 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders MYALGIA	44.4% 28/63 • Number of events 99 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	44.4% 28/63 • Number of events 52 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders NECK PAIN	6.3% 4/63 • Number of events 6 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	3.2% 2/63 • Number of events 2 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	22.2% 14/63 • Number of events 47 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.	17.5% 11/63 • Number of events 17 • Up to approximately 26 months Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.