Trial Outcomes & Findings for Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL (NCT NCT04938232)
NCT ID: NCT04938232
Last Updated: 2026-02-05
Results Overview
Patients achieving a complete (CR) or partial response (PR), assessed by PET/CT (using Lugano)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment
Results posted on
2026-02-05
Participant Flow
Participant milestones
| Measure |
Disease Progression After Previous Therapy
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL
Baseline characteristics by cohort
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=25 Participants
|
|
Age, Continuous
|
39 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=25 Participants
|
|
ECOG Performance Status Scale
0 - Fully active
|
6 Participants
n=25 Participants
|
|
ECOG Performance Status Scale
1 - Restricted in physically strenuous activity
|
6 Participants
n=25 Participants
|
|
ECOG Performance Status Scale
2 - Ambulatory and capable of all selfcare but unable to carry out any work activities
|
1 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatmentPatients achieving a complete (CR) or partial response (PR), assessed by PET/CT (using Lugano)
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Response Rate (ORR)
|
23 percent
Interval 7.0 to 49.0
|
SECONDARY outcome
Timeframe: 12 weeksPatients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Response Rate (ORR) Ipilimumab Monotherapy, Lugano
|
23 percent
Interval 7.0 to 49.0
|
SECONDARY outcome
Timeframe: 12 weeksPatients achieving complete (CR) or partial response (PR), assessed by PET/CT (using LYRIC criteria) after ipilimumab monotherapy
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Response Rate (ORR) Ipilimumab Monotherapy, LYRIC
|
23 percent
Interval 7.0 to 49.0
|
SECONDARY outcome
Timeframe: 12 weeksPatients achieving complete response (CR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Complete Response Rate (CRR) Ipilimumab Monotherapy, Lugano
|
0 percent
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 12 weeksPatients achieving complete response (CR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Complete Response Rate (CRR) Ipilimumab Monotherapy, LYRIC
|
0 percent
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 24 weeksPatients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab and nivolumab combination therapy
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, Lugano
|
15 percent
Interval 3.0 to 41.0
|
SECONDARY outcome
Timeframe: 24 weeksPatients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab and nivolumab combination therapy
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, LYRIC
|
8 percent
Interval 0.0 to 32.0
|
SECONDARY outcome
Timeframe: 2 yearsPercent of patients alive and progression-free at 2-years. Time from registration to progression or death, censored at date last known alive and progression-free using LYRIC criteria
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Progression-free Survival, LYRIC
|
38 percent
Interval 14.0 to 97.0
|
SECONDARY outcome
Timeframe: 2 years2-year percent DOR using Lugano criteria (LYRIC was equivalent). Time from first response (PR or CR) to progression, censored at last disease assessment.
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=3 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Duration of Response
|
100 percent
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsPercent of patients alive and progression-free at 2-years. Time from registration to progression or death, censored at date last known alive and progression-free using Lugano criteria
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Progression-free Survival, Lugano
|
49 percent
Interval 24.0 to 99.0
|
SECONDARY outcome
Timeframe: 2 yearsPercent OS at 2-years. Time from registration to death from any cause, censored at date last known alive
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Overall Survival
|
75 percent
Interval 43.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsWorst grade adverse event attributable (possibly, probably, definitely) to study treatment. Descriptions and grading scales per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
| Measure |
Disease Progression After Previous Therapy
n=13 Participants
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Percent of Patients With Grade 3+ Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
|
46 percent
Interval 22.0 to 71.0
|
Adverse Events
Disease Progression After Previous Therapy
Serious events: 6 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Disease Progression After Previous Therapy
n=13 participants at risk
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 3 • 120 weeks
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • Number of events 3 • 120 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Immune system disorders
Cytokine release syndrome
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
General disorders
Multi-organ failure
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Nervous system disorders
Spinal cord compression
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Vascular disorders
Thromboembolic event
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
Other adverse events
| Measure |
Disease Progression After Previous Therapy
n=13 participants at risk
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Nivolumab: Intravenous infusion
Ipilimumab: Intravenous infusion
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Shingles
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Thrush
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Investigations
Thyroid stimulating hormone increased
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Tooth infection
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Reproductive system and breast disorders
Vaginal dryness
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Metabolism and nutrition disorders
Obesity
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
General disorders
Fever
|
61.5%
8/13 • Number of events 11 • 120 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Number of events 10 • 120 weeks
|
|
General disorders
Fatigue
|
69.2%
9/13 • Number of events 10 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Number of events 7 • 120 weeks
|
|
Investigations
Alanine aminotransferase increased
|
46.2%
6/13 • Number of events 6 • 120 weeks
|
|
Investigations
Alkaline phosphatase increased
|
38.5%
5/13 • Number of events 6 • 120 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
4/13 • Number of events 6 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.5%
5/13 • Number of events 6 • 120 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
38.5%
5/13 • Number of events 5 • 120 weeks
|
|
Psychiatric disorders
Insomnia
|
38.5%
5/13 • Number of events 5 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.8%
4/13 • Number of events 5 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.8%
4/13 • Number of events 5 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.1%
3/13 • Number of events 4 • 120 weeks
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • Number of events 4 • 120 weeks
|
|
General disorders
Flu like symptoms
|
15.4%
2/13 • Number of events 4 • 120 weeks
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Number of events 4 • 120 weeks
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 4 • 120 weeks
|
|
Investigations
Platelet count decreased
|
23.1%
3/13 • Number of events 4 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
23.1%
3/13 • Number of events 4 • 120 weeks
|
|
General disorders
Chills
|
23.1%
3/13 • Number of events 3 • 120 weeks
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Number of events 3 • 120 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 3 • 120 weeks
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
2/13 • Number of events 3 • 120 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.4%
2/13 • Number of events 3 • 120 weeks
|
|
Investigations
Lipase increased
|
23.1%
3/13 • Number of events 3 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
15.4%
2/13 • Number of events 3 • 120 weeks
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 3 • 120 weeks
|
|
Psychiatric disorders
Anxiety
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Gastrointestinal disorders
Bloating
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Vascular disorders
Hypertension
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 2 • 120 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Investigations
Neutrophil count decreased
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Cardiac disorders
Palpitations
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Investigations
Weight loss
|
15.4%
2/13 • Number of events 2 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Gastrointestinal disorders
Colitis
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Investigations
CPK increased
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
General disorders
Gait disturbance
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Number of events 1 • 120 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place