Trial Outcomes & Findings for Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy (NCT NCT03719131)
NCT ID: NCT03719131
Last Updated: 2025-04-22
Results Overview
All patients will be evaluable for toxicity from the time of their first treatment with ipilimumab/nivolumab. Investigators will review the toxicities, grade, and attribute each toxicity.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At 6 months after study start
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
Arm A (Standard of Care)
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Nivolumab: Receive standard of care nivolumab therapy
Ipilimumab: Receive standard of care ipilimumab therapy
|
Arm B (Rituximab, Hyaluronidase Human)
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Nivolumab: Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Human: Given IV or SC
Ipilimumab: Receive standard of care ipilimumab therapy
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm A (Standard of Care)
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Nivolumab: Receive standard of care nivolumab therapy
Ipilimumab: Receive standard of care ipilimumab therapy
|
Arm B (Rituximab, Hyaluronidase Human)
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Nivolumab: Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Human: Given IV or SC
Ipilimumab: Receive standard of care ipilimumab therapy
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
Baseline Characteristics
Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy
Baseline characteristics by cohort
| Measure |
Arm A (Standard of Care)
n=7 Participants
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Nivolumab: Receive standard of care nivolumab therapy
Ipilimumab: Receive standard of care ipilimumab therapy
|
Arm B (Rituximab, Hyaluronidase Human)
n=7 Participants
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Nivolumab: Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Human: Given IV or SC
Ipilimumab: Receive standard of care ipilimumab therapy
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 6 months after study startPopulation: All patients were evaluated for toxicity from the time of their first treatment with ipilimumab/nivolumab.
All patients will be evaluable for toxicity from the time of their first treatment with ipilimumab/nivolumab. Investigators will review the toxicities, grade, and attribute each toxicity.
Outcome measures
| Measure |
Arm A (Standard of Care)
n=7 Participants
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Nivolumab: Receive standard of care nivolumab therapy
Ipilimumab: Receive standard of care ipilimumab therapy
|
Arm B (Rituximab, Hyaluronidase Human)
n=7 Participants
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Nivolumab: Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Human: Given IV or SC
Ipilimumab: Receive standard of care ipilimumab therapy
|
|---|---|---|
|
Number of Participants With Common Terminology Criteria (CTC) (Version [v]5.0) Grade 3 or Greater Immune-related Adverse Events
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeks after study startAll patients will be evaluable for toxicity from the time of their first treatment with ipilimumab/nivolumab. Investigators will review the toxicities, grade, and attribute each toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 weeks and every 12 weeks thereafter up to 1 yearWill be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune-related (ir)RECIST. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. Patients who exhibit objective disease progression prior to the end of cycle 1 will also be considered evaluable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 1 yearOverall survival is defined as the duration of time from start of treatment to time of death or last follow-up, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 1 yearPFS is defined as the duration of time from start of treatment to time of progression or death or last follow-up, whichever occurs first.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Standard of Care)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Arm B (Rituximab, Hyaluronidase Human)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A (Standard of Care)
n=7 participants at risk
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Nivolumab: Receive standard of care nivolumab therapy
Ipilimumab: Receive standard of care ipilimumab therapy
|
Arm B (Rituximab, Hyaluronidase Human)
n=7 participants at risk
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Nivolumab: Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Human: Given IV or SC
Ipilimumab: Receive standard of care ipilimumab therapy
|
|---|---|---|
|
Investigations
Hospitalization
|
57.1%
4/7 • Number of events 8 • 3 years and 4 months
|
57.1%
4/7 • Number of events 6 • 3 years and 4 months
|
Other adverse events
| Measure |
Arm A (Standard of Care)
n=7 participants at risk
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Nivolumab: Receive standard of care nivolumab therapy
Ipilimumab: Receive standard of care ipilimumab therapy
|
Arm B (Rituximab, Hyaluronidase Human)
n=7 participants at risk
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Nivolumab: Receive standard of care nivolumab therapy
Rituximab and Hyaluronidase Human: Given IV or SC
Ipilimumab: Receive standard of care ipilimumab therapy
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • Number of events 5 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 4 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
General disorders
Stabbing Lesion Pain (Back)
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash/itching (arms and legs)
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
General disorders
Joint pain
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 6 • 3 years and 4 months
|
57.1%
4/7 • Number of events 4 • 3 years and 4 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 6 • 3 years and 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Number of events 7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 3 • 3 years and 4 months
|
|
Endocrine disorders
Hyperthyroidism
|
28.6%
2/7 • Number of events 2 • 3 years and 4 months
|
28.6%
2/7 • Number of events 4 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 4 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Number of events 4 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (Hospitalization)
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
General disorders
General Disorders and Administration Site Conditions
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
14.3%
1/7 • Number of events 6 • 3 years and 4 months
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 12 • 3 years and 4 months
|
42.9%
3/7 • Number of events 6 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
14.3%
1/7 • Number of events 10 • 3 years and 4 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction (nivo reaction)
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
General disorders
Fever
|
57.1%
4/7 • Number of events 9 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough (dry cough)
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
0.00%
0/7 • 3 years and 4 months
|
|
General disorders
Abdominal Pain
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Nervous system disorders
AE Not Defined
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 6 • 3 years and 4 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/7 • 3 years and 4 months
|
57.1%
4/7 • Number of events 45 • 3 years and 4 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 6 • 3 years and 4 months
|
|
General disorders
Back Pain
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Ear and labyrinth disorders
Balance Impairment
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Bleeding from inguinal lesion
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 11 • 3 years and 4 months
|
|
General disorders
Blood in Urine
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Renal and urinary disorders
Bloody Discharge
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 11 • 3 years and 4 months
|
|
General disorders
Colitus
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 4 • 3 years and 4 months
|
|
Investigations
Elevated Creatinine
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 4 • 3 years and 4 months
|
|
Eye disorders
Eye Disorders
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 10 • 3 years and 4 months
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/7 • 3 years and 4 months
|
28.6%
2/7 • Number of events 6 • 3 years and 4 months
|
|
General disorders
Left Groin Pain
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Infections and infestations
Leukocytosis
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Gastrointestinal disorders
Loose Stools
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 4 • 3 years and 4 months
|
|
Blood and lymphatic system disorders
LUE + LLE Swelling
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and unspecified
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Paper Cut Infection
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 9 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash (Upper Back)
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 5 • 3 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rathke's Cyst (Pituitary)
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 2 • 3 years and 4 months
|
|
General disorders
Red blotches upper + lower trunk
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 1 • 3 years and 4 months
|
|
General disorders
Throat Tightness
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 4 • 3 years and 4 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Nervous system disorders
Trigeminal Nerve Disorder
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Gastrointestinal disorders
Watery Stool (Colitis)
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Worsening Rosacea
|
0.00%
0/7 • 3 years and 4 months
|
14.3%
1/7 • Number of events 3 • 3 years and 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place